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Clinician - Bulgarian speaker (for Central Review) - On-Demand

Clinician - Bulgarian speaker (for Central Review) - On-Demand

Remote Office

Job Summary

MedAvante is the clinical data sciences company that is revolutionizing drug development with smarter, faster clinical trials. The Principal Clinician – Central Review evaluates the administration of standardized structured and semi-structured diagnostic and severity assessments and provides constructive feedback to the clinicians at clinical trial sites who conduct these assessments. If you want to be part of a clinical team dedicated to unlocking new, more effective treatments and enhancing the lives of patients and those who care for them, this is an opportunity you should investigate.

Responsibilities

  • Provide scoring for site assessments and review site scores.
  • Review site assessments for quality assurance.
  • Submit accurate review of site data utilizing standardized conventions.
  • Utilize technology required to review and score site assessments.
  • Work with MedAvante Project Associates to schedule assessment reviews, submit appropriate review documentation and provide data clarification.
  • Follow Sponsor (protocol-specific) requirements and applicable Good Clinical Practices and MedAvante internal SOPs.
  • May participate in Clinical and Team meetings.
  • Participate in on-going Clinician scoring exercises and training.
  • May assume primary responsibility for major research and other projects.
  • May participate in staff meetings.
  • Responsible for keeping up to date with departmental and company communications to ensure one follows current policies, scale conventions, study procedures, and other pertinent information.

Job Requirements:

  • Minimum of a Master’s degree conferred by a clinically-focused program in a mental health discipline such as Psychology, Social Work, Counseling or Psychiatric Nursing.
  • Minimum of 2 years clinical experience diagnosing and/or treating patients with neurocognition disorders.
  • Minimum of 2 years administering standardized assessment tools (MMSE, ADAS-Cog, CDR, ADCS-ADLI)

  • Proficiency with MS Word, Excel, Outlook and PowerPoint.
  • Knowledge of GCP guidelines.
  • Strong communication skills, oral and written.
  • Bulgarian native speaker
  • Intermediate or advanced proficiency in English preferred.
  • Ability to work collaboratively within the company.

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Remote Office
Clinician - Bulgarian speaker (for Central Review) - On-Demand

Clinician - Bulgarian speaker (for Central Review) - On-Demand

Remote Office

Job Summary

MedAvante is the clinical data sciences company that is revolutionizing drug development with smarter, faster clinical trials. The Principal Clinician – Central Review evaluates the administration of standardized structured and semi-structured diagnostic and severity assessments and provides constructive feedback to the clinicians at clinical trial sites who conduct these assessments. If you want to be part of a clinical team dedicated to unlocking new, more effective treatments and enhancing the lives of patients and those who care for them, this is an opportunity you should investigate.

 

Responsibilities

  • Submit accurate review of site data utilizing standardized conventions.
  • Utilize technology required to review and score site assessments.
  • Work with MedAvante Project Associates to schedule assessment reviews, submit appropriate review documentation and provide data clarification.
  • Follow Sponsor (protocol-specific) requirements and applicable Good Clinical Practices and MedAvante internal SOPs.
  • Conduct trainings for site raters.
  • May participate in Clinical and Team meetings.
  • Participate in on-going Clinician calibration and training.
  • May participate in staff meetings.
  • Responsible for keeping up to date with departmental and company communications to ensure one follows current policies, scale conventions, study procedures, and other pertinent information.

Job Requirements:

  • Minimum of a Master’s degree conferred by a clinically-focused program in a mental health discipline such as Psychology, Social Work, Counseling or Psychiatric Nursing.
  • Minimum of 2 years clinical experience diagnosing and/or treating patients with psychiatric disorders
  • Familiar with administering the PANSS scale
  • Ability to conduct reviews of rater severity and/or diagnostic sessions, providing feedback for quality control purposes.

  • Proficiency with MS Word, Excel, Outlook and PowerPoint.
  • Knowledge of GCP guidelines.
  • Strong communication skills, oral and written.
  • Bulgarian native speaker
  • Intermediate or advanced proficiency in English preferred.
  • Ability to work collaboratively within the company.

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Remote Office
Clinician (home-based, on-demand) for Singapore

Clinician (home-based, on-demand) for Singapore

Remote Office

Job Summary

MedAvante is the clinical data sciences company that is revolutionizing drug development with smarter, faster clinical trials. The Clinician evaluates the administration of standardized structured and semi-structured diagnostic and severity assessments and provides constructive feedback to the clinicians at clinical trial sites who conduct these assessments. If you want to be part of a clinical team dedicated to unlocking new, more effective treatments and enhancing the lives of patients and those who care for them, this is an opportunity you should investigate.

This position is home-based (any location).

Responsibilities

  • Submit accurate review of site data utilizing standardized conventions.
  • Utilize technology required to review and score site assessments.
  • Work with MedAvante Project Associates to schedule assessment reviews, submit appropriate review documentation and provide data clarification.
  • Follow Sponsor (protocol-specific) requirements and applicable Good Clinical Practices and MedAvante internal SOPs.
  • May participate in Clinical and Team meetings.
  • Participate in on-going Clinician scoring exercises and training.
  • May participate in staff meetings.
  • Responsible for keeping up to date with departmental and company communications to ensure one follows current policies, scale conventions, study procedures, and other pertinent information.

Job Requirements:

  • Minimum of a Master’s degree conferred by a clinically-focused program in a mental health discipline such as Psychology, Social Work, Counseling or Psychiatric Nursing.
  • Minimum of 2 years clinical experience diagnosing and/or treating patients with psychiatric disorder, neurocognition disorders and/or other study relevant indications.
  • 2 or more years administering study relevant standardized assessment tools and/or 2 years of working as a MedAvante clinician.

  • Proficiency with MS Word, Excel, Outlook and PowerPoint.
  • Knowledge of GCP guidelines.
  • Strong communication skills, oral and written.
  • Proficient in Malay and English as spoken in Singapore.
  • Ability to work collaboratively within the company.

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Hamilton, NJ
Customer Support Specialist II

Customer Support Specialist II

Hamilton, NJ

Job Summary

 

The Customer Support Specialist II provides Tier I level support to external MedAvante customers.  May provide assistance or train less experienced support specialists on the handling of complicated issues.

Responsibilities

  • Lead and support Customer Support Specialists.
  • Train new hires on help desk policies and procedures.
  • Answer inbound calls and e-mails, determine customer problems through asking appropriate questions, and help customers resolve issues.
  • Investigate, resolve and escalate issues to the appropriate internal team members.
  • Log calls and resolutions through Salesforce database system.
  • Train and stay current on all present and future internal systems and devices.
  • Assist with defining policies and procedures to improve call handling and resolution process.
  • Work in a team environment supporting a 24x5 call center.
  • Possess general understanding of the company Systems and Methodology. 
  • Assist Management with requested reports and other activities that may be requested.
  • Assist with creating/updating SOPs and Work Instructions as needed.
  • Occasional flexibility in work hours may be required in order to cover vacations, training sessions and other similar company activities.
  • Assist in daily operations including, but not limited to, telephone and email support, diagnosing problems and completing regularly scheduled activities.
  • May be required to schedule and/or initiate clinical assessments.
  • May be required to enter clinical assessment data points into one or more systems.

 

Note:  Other duties may be assigned by Management

 

Education / Qualifications:

 

  • Bachelor’s degree preferred or equivalent professional experience. 
  • 3 + years’ experience providing technical trouble-shooting support over the telephone and via e-mail or 3 + years’ Clinical trial experience with direct site/sponsor contact.

 

Experience / Skills
 

  • Strong customer service and clear and concise verbal communication skills, especially over the telephone.  This includes the ability to ask questions to quickly and accurately understand customer issues as well as the ability to communicate/translate technical concepts and instructions to non-technical customers.
  • Demonstrated technical problem solving capabilities.
  • Excellent written and verbal skills are necessary to effectively convey directions and information to both external customers and internal team members.
  • Ability to successfully handle and prioritize multiple work requests and/or projects simultaneously with little or no immediate supervision.
  • Ability to learn new technical skills and processes quickly.
  • Ability to work under pressure.
  • Must possess good leadership qualities to inspire people to reach their full potential.
  • Must be knowledgeable about service desk system and IT tools.
  • Possess strong analytical and problem solving skills.
  • Possess good interpersonal skills and attention to customer service.
  • Proficient in Microsoft Office.

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Hamilton, NJ
Customer Support Specialist I

Customer Support Specialist I

Hamilton, NJ

Job Summary

 

The Customer Support Specialist I provides Tier 1 level support to external MedAvante customers.

Responsibilities

  • Answer inbound calls and e-mails, determine customer problems through asking appropriate questions, and help customers resolve issues.
  • Investigate, resolve and escalate issues to the appropriate internal team member.
  • Log calls and resolutions through our Salesforce database system.
  • Train and stay current on all present and future internal systems and devices.
  • Work in a team environment supporting a 24 x 5 call center.
  • Possess general understanding of the company Systems and Methodology.
  • Occasional flexibility in work hours may be required in order to cover for vacations, training sessions and other similar company activities.
  • Assist in daily operations including, but not limited to, telephone and email support, diagnosing problems and completing regularly scheduled activities.
  • May be required to schedule and/or initiate clinical assessments.
  • May be required to enter clinical assessment data points into one or more systems.
  • Other duties as assigned by Management

 

Education / Qualifications:

 

  • Bachelor’s or Associate’s degree preferred or equivalent professional experience.
  • 1 + years’ experience providing technical trouble-shooting support over the telephone and via e-mail or 1 + years’ Clinical trial experience with direct site/sponsor contact.

 

Experience / Skills
 

  • Strong customer service and clear and concise verbal communication skills, especially over the telephone.  This includes the ability to ask questions to quickly and accurately understand customer issues as well as the ability to communicate/translate technical concepts and instructions to non-technical customers.
  • Demonstrated technical problem solving capabilities.
  • Excellent written and verbal skills are necessary to effectively convey directions and information to both external customers and internal team members.
  • Ability to successfully handle and prioritize multiple work requests and/or projects simultaneously with little or no immediate supervision.
  • Possess strong analytical and problem solving skills.
  • Possess good interpersonal skills and attention to customer service.
  • Ability to learn new technical skills and processes quickly.
  • Proficient in Microsoft office.

 

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Hamilton, NJ
Application Architect

Application Architect

Hamilton, NJ

Summary

The Application Architect is a key member of the Development Team and is responsible for the architectural oversight and implementation of the business application development projects. The Application Architect also interacts closely with the Design Architect, Business Analysts and Product owners in understanding requirements provided by the stakeholders and be able to drive the implementation process by efficiently translating the requirements into technical solutions. 

Essential duties include: - Responsible for the detailed design and implementation of new applications and systems; support business and regulatory testing of applications, oversee troubleshooting of various application support issues, and able to assist managing the development team. The ideal candidate will provide leadership and guidance to the development team in building stable and scalable business applications with an effective architectural strategy to create a solution by balancing the appropriate development concepts.

Responsibilities

  • Assist with architecture and detailed design of new business applications and re-architecture and re-design of current business applications
  • Lead the team in understanding and converting business requirements into solutions
  • Provide mentorship and technical guidance to members of the development team
  • Oversee implementation of best practices and the code review processes
  • Assist in developing and refining the application development process
  • Work with Regulatory/Q&A in the development of the appropriate validation documentation and processes
  • Assist the testing team with the development of testing activities along with defining and overseeing a test driven software development process
  • Assisting the business analyst(s) to help establish the business requirements
  • Other responsibilities as assigned by management.

Requirements

  • BS/Master’s degree or equivalent in computer application.
  • At least 10 years of experience in application development with Microsoft .NET technologies; including C#
  • At least 5 years of experience with Architecture, design patterns, advanced SQL query-writing, stored procedure development, database design and development; including MS SQL Server
  • Expertise in using .NET 4.51/4.5/4.0, C#, ASP.NET, VB.NET, Web API, WCF Web services, SQL Server 2008, ADO.NET, Visual Studio 2010 & 2012, XML, HTML5, JavaScript, jQuery, JSON, XSLT, AJAX, UML, Visio, Angular JS, Responsive Web Design, Telerik
  • Extensive experience with JS Frameworks such as AngularJS, Node.js or any others
  • Experience with large scale integrations with third party API and tools
  • Experience with Service Oriented Architecture (SOA), Restful Web Services and API based development
  • Strong understanding of Agile development principles
  • Good understanding of SOLID Design principles
  • Understanding of data modeling and design considerations for analytical systems
  • Expertise in distributed systems architecture, design, and development
  • Expertise in developing Web/Mobile/Desktop applications
  • Experience with full software development life-cycle including functional requirements gathering with business users, development, unit testing, QA testing, implementation, and post-implementation support
  • Strong communication skills with the ability to explain complex technical issues to non-technical team members and clients
  • Active learner and with the ability to teach and mentor peers and junior staff
  • Familiarity of automated software testing
  • Experience developing solutions for use in life sciences (e.g. pharmaceutical industry or clinical research) including clinical trials, would be a plus.

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Hamilton, NJ
Clinical Specialist, eForm Development

Clinical Specialist, eForm Development

Hamilton, NJ

Job Summary

The Clinical Specialist in eForm Development supports development of Virgil eForms from a clinical perspective across therapeutic areas in conjunction with IT Development. The Clinical Specialist will be responsible for ensuring timely completion of Virgil eForms while adhering to quality standards and clinical validity. This individual will have experience conducting assessments in clinical trials as well as interacting with investigative sites and study sponsors. The incumbent will assist in ensuring the organization’s operational efficacy and excellence by working with the different operational units in translating groups’ business requirements to particular software requirements and/or procedural workflows.

Responsibilities

  • Provide clinical subject matter expertise in the development of Virgil eForms to meet the client’s business needs.
  • Communicate and coordinate effectively with internal teams to deliver requirements for electronic form layout, interface and validation rules/edit checks.
  • Provide support to the Business Analyst and Test teams through Clinical validation expertise to test, validate and evaluate work completed by the eForms team.
  • Participate in team meetings and communicate regularly with remote staff and other employees.
  • Review and evaluate data collected through Virgil, Central Ratings, Central Review, internal usability testing, surveys, and marketing research to improve functionality and clinical guidance included in eForms.
  • Liaise with sponsors and scale authors, as needed.
  • External facing clinical representative responsible for presenting eForm batteries utilized in large, international clinical trials, to sponsors for approval/adoption.
  • Work with the operational groups who test, validate and evaluate new applications and functions, and determine clinical related issues in services and software.
  • Identify the need for and develop as needed work instructions, process guidelines and standard operating procedures and ensure processes and procedures meet SOP/GCP requirements related to eForm development.
  • Evaluate a patient’s current clinical condition and symptom severity as needed and MedAvante qualified.
  • Perform diagnostic assessments as needed and MedAvante qualified.
  • May also review, score, and provide feedback to site raters regarding the administration of standardized structured and semi-structured diagnostic and severity assessments as needed and MedAvante Qualified.
  • Conduct trainings for site raters as needed and MedAvante qualified.
  • Perform other job duties as assigned by management.

 

Education / Qualifications:

  • Graduate degree in psychology, social work, counseling, psychiatric nursing or related field.
  • Minimum 4 years’ experience administering standardized assessment tools, psychiatric symptom rating scales and/or Neurocognition scales, experience with structured diagnostic interviews preferred.
  • Minimum 2 years’ experience in a clinical trial or research setting or other clinical setting is highly preferred.
  • Knowledge of clinical assessment best practices.
  • Fluent in English, bi-lingual or multi-lingual skills are preferred.
  • Basic understanding of GCP.

 

 

Experience / Skills:

 

  • Ability to function effectively in a fast paced environment and manage multiple projects simultaneously.
  • Demonstrate leadership skills and ability to manage, motivate, and integrate a team.
  • Strong problem solving/decision making skills.
  • Effective project management skills.
  • Ability to think analytically and adept at problem solving.
  • Solid understanding of basic and intermediate statistics.
  • Strong written and oral communication skills.
  • Strong interpersonal and organizational skills.
  • Demonstrate negotiation skills.
  • Ability to lead through influencing and negotiating.
  • Strong facilitation and coordination skills.
  • Ability to multi-process, delegate project tasks.
  • Advanced skills in MS Word, Excel, and Adobe.

 


 

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Hamilton, NJ
Project Manager

Project Manager

Hamilton, NJ

Job Summary:

The Project Manager is responsible for the day-to-day management of client projects and ensures that projects are delivered on time, within budget and according to client expectations.

 

Responsibilities:

  • Provide leadership in the delivery of services to clients, reviews work produced by the project teams, and ensures that staff fulfills their responsibilities in accordance with project contracts and MedAvante policies, procedures and SOPs.
  • Possess the ability to provide practical solutions to problems and situations ordinarily encountered.
  • Experience in strategic analysis, developing project plans, budgeting, scheduling, risk management, resource allocation, and scope management.
  • Manage the project implementation with highest customer satisfaction.
  • Assist in the supervision and training of new and adjunct staff.
  • Build relationships with customer contacts.
  • Lead kickoff, design, status, and other project related meetings with cross-functional teams and project stakeholders at all levels.
  • Present study services at client meetings, such as at Study Monitor Meetings, Investigator Meetings, and project initiation (kick-off) meetings.
  • Train investigative sites on study procedures.
  • Develop complex project schedules, and manage project cost, scope, schedule and quality, as well as profitability.
  • Experience in leading and managing internal project teams and experience coordinating and managing multiple project efforts simultaneously.
  • Lead project discussions, including post-mortems and project checkpoints.
  • Closely manage the entire project life cycle. Identify and track issues, risks, dependencies, efficiencies, and critical path objectives.  Escalate as necessary.
  • As part of project status tracking and reporting, continuously assess project risk factors and recommend appropriate courses of action to mitigate.
  • Provide timely and audience-specific status reports in support of defined metrics to the Senior Vice President, Global Operations and other key stakeholders.
  • Perform other job duties as determined by the Associate Director, Project Management or senior management.

 

Education / Qualifications:

  • Bachelor’s degree in related field and/or 3 to 5 years related experience in a clinical project management environment (e.g.CRO, pharmaceutical company, or other centralized service provider used in clinical studies) or the equivalent combination of education, skills and experience to perform the job.
  • PMP Certification preferred.
  • Experience with clinical trials in CNS, Alzheimer’s/Dementia preferred.
  • Minimum of 1 year supervisory experience recommended.
  • Knowledge of project management software tools and management techniques.

 

Experience / Skills:

  • Possess demonstrated experience in developing complete project plans and executing the management and implementation of those plans on time and within budget.
  • Must have first-hand experience with all stages of the project life-cycle, from requirements gathering to completion of project.
  • Ability to function effectively in a fast paced environment and manage multiple projects simultaneously.
  • Demonstrated leadership skills and ability to manage, motivate, and integrate a team.
  • Excellent problem solving/decision making skills.
  • Proven project management experience.
  • Outstanding written and oral communication skills.
  • Excellent organizational skills.
  • Demonstrated negotiation skills.
  • Excellent interpersonal skills. Ability to lead through influencing and negotiating.
  • Strong facilitation and coordination skills.
  • Ability to multi-process, delegate project tasks.
  • Demonstrated understanding and compliance with MedAvante Employee Manual.
  • Proficient knowledge of MS Office, specifically Word, Excel, Access and PowerPoint as well as Adobe, Visio and MS Project and the ability to produce detailed reports and presentations using these tools.
  • Possess a valid driver’s license and passport.


 

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U.S. - Any Location
Principal Clinician - Central Review (US - East or West Coast) On Demand

Principal Clinician - Central Review (US - East or West Coast) On Demand

U.S. - Any Location

Job Summary

MedAvante is the clinical data sciences company that is revolutionizing drug development with smarter, faster clinical trials. The Principal Clinician - Central Review evaluates the administration of standardized structured and semi-structured diagnostic and severity assessments and provides constructive feedback to the clinicians at clinical trial sites who conduct these assessments. If you want to be part of a clinical team dedicated to unlocking new, more effective treatments and enhancing the lives of patients and those who care for them, this is an opportunity you should investigate.

Responsibilities

  • Provide scoring for site assessments and review site scores.
  • Review site assessments for quality assurance.
  • Submit accurate review of site data utilizing standardized conventions.
  • Utilize technology required to review and score site assessments.
  • Work with MedAvante Project Associates to schedule assessment reviews, submit appropriate review documentation and provide data clarification.
  • Follow Sponsor (protocol-specific) requirements and applicable Good Clinical Practices and MedAvante internal SOPs.
  • May participate in Clinical and Team meetings.
  • Participate in on-going Clinician scoring exercises and training.
  • May assume primary responsibility for major research and other projects.
  • May participate in staff meetings.
  • Responsible for keeping up to date with departmental and company communications to ensure one follows current policies, scale conventions, study procedures, and other pertinent information.

Job Requirements:

  • Minimum of a Master’s degree conferred by a clinically-focused program in a mental health discipline such as Psychology, Social Work, Counseling or Psychiatric Nursing.
  • Minimum of 2 years clinical experience diagnosing and/or treating patients with psychiatric disorder, neurocognition disorders and/or other study relevant indications.
  • 2 or more years administering study relevant standardized assessment tools and/or 2 years of working as a MedAvante clinician.
  • Proficiency with MS Word, Excel, Outlook and PowerPoint.
  • Knowledge of GCP guidelines.
  • Strong communication skills, oral and written
  • Intermediate or advanced proficiency in English preferred.
  • Ability to work collaboratively within the company.

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Remote Office
Clinician (home-based, on-demand) for Hong Kong

Clinician (home-based, on-demand) for Hong Kong

Remote Office

Job Summary

MedAvante is the clinical data sciences company that is revolutionizing drug development with smarter, faster clinical trials. The Clinician evaluates the administration of standardized structured and semi-structured diagnostic and severity assessments and provides constructive feedback to the clinicians at clinical trial sites who conduct these assessments. If you want to be part of a clinical team dedicated to unlocking new, more effective treatments and enhancing the lives of patients and those who care for them, this is an opportunity you should investigate.

This position is home-based (any location).

Responsibilities

  • Submit accurate review of site data utilizing standardized conventions.
  • Utilize technology required to review and score site assessments.
  • Work with MedAvante Project Associates to schedule assessment reviews, submit appropriate review documentation and provide data clarification.
  • Follow Sponsor (protocol-specific) requirements and applicable Good Clinical Practices and MedAvante internal SOPs.
  • May participate in Clinical and Team meetings.
  • Participate in on-going Clinician scoring exercises and training.
  • May participate in staff meetings.
  • Responsible for keeping up to date with departmental and company communications to ensure one follows current policies, scale conventions, study procedures, and other pertinent information.

Job Requirements:

  • Minimum of a Master’s degree conferred by a clinically-focused program in a mental health discipline such as Psychology, Social Work, Counseling or Psychiatric Nursing.
  • Minimum of 2 years clinical experience diagnosing and/or treating patients with psychiatric disorder, neurocognition disorders and/or other study relevant indications.
  • 2 or more years administering study relevant standardized assessment tools and/or 2 years of working as a MedAvante clinician.

  • Proficiency with MS Word, Excel, Outlook and PowerPoint.
  • Knowledge of GCP guidelines.
  • Strong communication skills, oral and written.
  • Proficient in Cantonese and English as spoken in Hong Kong.
  • Ability to work collaboratively within the company.

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Hamilton, NJ
Contract Manager

Contract Manager

Hamilton, NJ

The Contract Manager is responsible for managing the contract execution process including negotiation of contracts for customer projects, vendors, etc., including soliciting input and review from applicable functional areas.  Interact with MedAvante’s corporate attorney and all levels of management as necessary to determine the appropriate terms and conditions to be included in the contracts.  This position reports to the Director, Finance.

Responsibilities

The Contract Manager will work with the corporate attorney and internal management to develop and negotiate contracts; including but not limited to:

  1. Customer (Service) Agreements
  2. Change Orders
  3. Vendor Agreements
  4. Non-Disclosure Agreements
  5. License Agreements
  • Review contract terms and conditions relative to company standard templates and interact with the corporate attorney, internal management, and outside contracting parties to reduce or eliminate Company’s risk / financial exposure.
  • When working with the corporate attorney, review attorney’s proposed contract modifications and make recommendations based on industry standards, MedAvante policies and procedures, reasonableness, acceptable risk to MedAvante, etc.
  • In coordination with internal management, work directly with customer outsourcing and legal staff to negotiate until consensus has been reached.
  • Work with business development staff to finalize Statement of Work for inclusion in customer service agreement.
  • Work with operations and business development staff to draft change orders and manage through execution.
  • Manage customer questionnaire responses including coordinating with operations, IT and Regulatory & Quality Assurance as needed. 
  • Provide consultation and negotiation support to business partners.
  • Distribute finalized documents as necessary and maintain electronic and hard copy master contract files.
  • Identify and drive continuous improvement to the contract process.
  • Other duties as required by management.

Education / Qualifications:

  • Bachelor’s degree required preferably in Business, Operations, Economics or Finance.
  • 5 years’ work experience in a contract management role in a mid-size company or contracts service provider. 
  • Prior experience with either a pharmaceutical company or Contract Research Organization (“CRO”).
  • Clinical development experience is a plus.
  • Excellent negotiating and persuasive skills, both in one-on-one and group situations. 
  • Strong oral and written communication skills with the ability to convey complex information in a way that others can readily follow.
  • Strong organizational skills and the ability to meet strict timelines.
  • Experience using MS Office products.
  • Possess the skills to work both independently and as part of a team in a fast-paced, high pressure environment.
  • Attention to detail and ability to self-prioritize work on an ongoing basis.
  • Willingness to work overtime as needs of projects dictate.

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Japan
Receptionist

Receptionist

Japan

Job Summary:

The Receptionist is responsible for all front desk reception duties including administrative duties in support of departmental operations.  Relieve staff of clerical and administrative work by performing assigned tasks.  Customer service is the number one priority for this position.

Our office is located in Tokyo, close to Senzoku station.

Responsibilities

  • Responsible for greeting visitors and ensuring they sign in and are given a visitor’s pass.

  • Responsible for posting outgoing mail and receiving and delivering incoming mail and packages.This includes receiving and signing for Fed Ex and other overnight deliveries.

  • Responsible for printing daily conference room schedules and placing outside appropriate conference room.

  • Responsible for maintaining a clutter-free workstation and ensuring reception area is neat and clean.

  • Responsible for maintaining parking pass and FOB security logs.

  • Responsible for maintaining copy machines and related supplies.

  • Responsible for setting up kitchen each morning and closing it down in the evening.This involves loading and unloading the dishwasher and putting coffee cups and flatware in cupboards and drawers.Additionally, ensures kitchen is stocked with coffee, creamer, sugar etc. daily. Works with Sr. Executive Assistant/Facilities Supervisor to ensure kitchen supplies are ordered and maintained.

  • Assists all departments with administrative duties such as typing, copying, mass mailings or other projects as specified by the Sr. Executive Assistant/Facilities Supervisor.

  • Organizes and maintains file system; prepares labels and tabs.

  • Answers, screens and routes telephone calls and arranges conference calls.

  • Support administrative team members and Sr. Executive Assistant/Facilities Supervisor with making travel arrangements and ordering supplies, as needed

  • Assists administrative team members as needed.

  • Prompt arrival each morning and regular attendance at work.

     

    Education / Qualifications:

  • College degree (Associate’s or Bachelor’s) or professional certification in related field, preferred.

  • Requires at least two (2) years of Reception/Administrative Assistant experience

  • Proficient in Microsoft Office including Word, Excel, PowerPoint, Outlook, and Access.

  • Experience with domestic and international travel arrangements.

  • Domestic and international shipping experience.

  • Strong verbal and written communication and interpersonal skills.

  • Pleasant and cooperative attitude with a diverse group of co-workers and guests/visitors.

  • Knowledge of general office practices and procedures.

  • Professional appearance; grooming and dress consistent with desired corporate image.

  • Courteous and efficient telephone manners, including prompt and courteous routing of calls; speaks clearly and in a friendly manner at all times.

  • Ability to follow through on work assignments in a timely and organized manner.

  • Ability to multi-task in addition to performing regular reception duties.

     

    Experience / Skills

  • Native /near native Japanese skills (oral and written)

  • Good English skills

  • Ability to work in a fast-paced environment

  • Professional attitude

  • Strong organizational, communication, and interpersonal skills

  • Effective multi-tasking skills

  • Good attention to detail

  • Ability to work independently and on a team.

  • Customer service friendly

  • Maintains confidentiality

  • Remains open to others' ideas and tries new things

  • Listens and gets clarification

  • Responds well to questions

  • Aligns work with strategic goals

  • Works with integrity and ethically

  • Upholds organizational values

  • Ensures work responsibilities are covered when absent

  • Demonstrates accuracy and thoroughness

     

    Management reserves the right to modify this job description at any time, according to business needs.

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Hamilton, NJ
Alliance Management

Alliance Management

Hamilton, NJ

Job Summary

The incumbent is responsible for establishing or enhancing business relationships and partnerships between MedAvante and other key stakeholders in clinical trials. Activities will be targeted towards increasing the request-for-proposal (RFP) volume MedAvante receives via alliance partners, enhancing the competitive differentiation and adoption of our solutions in the market space and improving the efficiency of our products via interoperability with other technology platforms. Potential partnerships include CROs, technology providers for clinical trials, site management organizations, key opinion leaders (KOLs) and other stakeholders. Incumbent will be a member of the Business Development team and will be collaborating with other departments such as Product Management, IT and the Executive Team.

Responsibilities

  • Establish relationships with other trial stakeholders such as CROs to create new business opportunities and sales channels for MedAvante.
  • Develop the commercial concept and components of partnering agreements.
  • Manage established partnering contacts on the daily level and facilitate C-level dialogue.
  • Analyze trends in the clinical trial industry (risk-based monitoring, data analytics, site networks, sensor devices) for potential partnering opportunities.
  • Collaborate with Business Development Team on closing business.
  • Present MedAvante capabilities to potential partners (e.g. CRO proposal teams).
  • Perform networking activities at conferences and special interest group meetings.
  • Ability and willingness to travel (domestically and internationally), estimated 20%.

Education / Qualifications:

  • BS/BA degree.  Master’s preferred.
  • Seven (7) plus years’ of industry experience, either from working at a clinical service company (CRO) or e-clinical technology company (e.g. EDC vendor) in an alliance management, corporate development or business development role.
  • Experience in and in-depth knowledge of clinical trial services (e.g. traditional monitoring, risk-based monitoring, data analytics).
  • Five (5) years’ experience in a leadership position.
  • Experience developing and executing partnering go-to-market plans.
  • Team player with strong drive and willing to take a leadership role in driving initiatives, working effectively across the organization and creating unique approaches to developing new revenue opportunities.   

Experience / Skills

  • Proven success building strategic business and alliance plans.
  • Strong knowledge of the CRO and clinical trial service industry.
  • Strong business and analytic acumen.
  • Strategic thinker who is capable of blending technical and business strategy to develop compelling partnering initiatives.
  • Demonstrated networking, persuasion and presentation skills.
  • Ability to simplify complex concepts and make them relatable to potential partners.
  • Ability to adjust to new, different or changing requirements.
  • Strong written and verbal communication skills.
  • Demonstrates different influence styles as appropriate to situation while maintaining positive relationships.
  • Proficiency in Microsoft Office Suite.

 

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Remote Office
Clinician / Neurologist - Spanish speaker (for Central Review) - On-Demand

Clinician / Neurologist - Spanish speaker (for Central Review) - On-Demand

Remote Office

Job Summary

MedAvante is the clinical data sciences company that is revolutionizing drug development with smarter, faster clinical trials. The Clinician evaluates the administration of standardized structured and semi-structured diagnostic and severity assessments and provides constructive feedback to the clinicians at clinical trial sites who conduct these assessments. If you want to be part of a clinical team dedicated to unlocking new, more effective treatments and enhancing the lives of patients and those who care for them, this is an opportunity you should investigate.

Responsibilities

  • Submit accurate review of site data utilizing standardized conventions.
  • Utilize technology required to review and score site assessments.
  • Work with MedAvante Project Coordinators to schedule assessment reviews, submit appropriate review documentation and provide data clarification.
  • Follow Sponsor (protocol-specific) requirements and applicable Good Clinical Practices and MedAvante internal SOPs.
  • Participate in on-going Clinician scoring exercises and training.
  • Responsible for keeping up to date with departmental and company communications to ensure one follows current policies, scale conventions, study procedures, and other pertinent information.

Job Requirements:

  • Clinicians must have a qualification as a Medical Doctor with a specialization in the field of Neurology.
  • Minimum 2 years’ clinical experience diagnosing and/or treating patients with psychiatric disorders, neurocognition disorders, and/or other study relevant indications.
  • 2 or more years administering study relevant standardized assessment tools, including a minimum of 2 years experience administering movement disorder scales (MDS UPDRS , etc.).
  • Proficiency with MS Word, Excel, Outlook and PowerPoint.
  • Knowledge of GCP guidelines.
  • Strong communication skills, oral and written.
  • Spanish native speaker
  • Intermediate or advanced proficiency in English preferred.
  • Ability to work collaboratively within the company.

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Remote Office
Clinician / Neurologist - French speaker (for Central Review) - On-Demand

Clinician / Neurologist - French speaker (for Central Review) - On-Demand

Remote Office

Job Summary

MedAvante is the clinical data sciences company that is revolutionizing drug development with smarter, faster clinical trials. The Clinician evaluates the administration of standardized structured and semi-structured diagnostic and severity assessments and provides constructive feedback to the clinicians at clinical trial sites who conduct these assessments. If you want to be part of a clinical team dedicated to unlocking new, more effective treatments and enhancing the lives of patients and those who care for them, this is an opportunity you should investigate.

Responsibilities

  • Submit accurate review of site data utilizing standardized conventions.
  • Utilize technology required to review and score site assessments.
  • Work with MedAvante Project Coordinators to schedule assessment reviews, submit appropriate review documentation and provide data clarification.
  • Follow Sponsor (protocol-specific) requirements and applicable Good Clinical Practices and MedAvante internal SOPs.
  • Participate in on-going Clinician scoring exercises and training.
  • Responsible for keeping up to date with departmental and company communications to ensure one follows current policies, scale conventions, study procedures, and other pertinent information.

Job Requirements:

  • Clinicians must have a qualification as a Medical Doctor with a specialization in the field of Neurology.
  • Minimum 2 years’ clinical experience diagnosing and/or treating patients with psychiatric disorders, neurocognition disorders, and/or other study relevant indications.
  • 2 or more years administering study relevant standardized assessment tools, including a minimum of 2 years experience administering movement disorder scales (MDS UPDRS , etc.).
  • Proficiency with MS Word, Excel, Outlook and PowerPoint.
  • Knowledge of GCP guidelines.
  • Strong communication skills, oral and written.
  • French native speaker
  • Intermediate or advanced proficiency in English preferred.
  • Ability to work collaboratively within the company.

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Remote Office
Clinician / Neurologist - German speaker (for Central Review) - On-Demand

Clinician / Neurologist - German speaker (for Central Review) - On-Demand

Remote Office

Job Summary

MedAvante is the clinical data sciences company that is revolutionizing drug development with smarter, faster clinical trials. The Clinician evaluates the administration of standardized structured and semi-structured diagnostic and severity assessments and provides constructive feedback to the clinicians at clinical trial sites who conduct these assessments. If you want to be part of a clinical team dedicated to unlocking new, more effective treatments and enhancing the lives of patients and those who care for them, this is an opportunity you should investigate.

Responsibilities

  • Submit accurate review of site data utilizing standardized conventions.
  • Utilize technology required to review and score site assessments.
  • Work with MedAvante Project Coordinators to schedule assessment reviews, submit appropriate review documentation and provide data clarification.
  • Follow Sponsor (protocol-specific) requirements and applicable Good Clinical Practices and MedAvante internal SOPs.
  • Participate in on-going Clinician scoring exercises and training.
  • Responsible for keeping up to date with departmental and company communications to ensure one follows current policies, scale conventions, study procedures, and other pertinent information.

Job Requirements:

  • Clinicians must have a qualification as a Medical Doctor with a specialization in the field of Neurology.
  • Minimum 2 years’ clinical experience diagnosing and/or treating patients with psychiatric disorders, neurocognition disorders, and/or other study relevant indications.
  • 2 or more years administering study relevant standardized assessment tools, including a minimum of 2 years experience administering movement disorder scales (MDS UPDRS , etc.).
  • Proficiency with MS Word, Excel, Outlook and PowerPoint.
  • Knowledge of GCP guidelines.
  • Strong communication skills, oral and written.
  • German native speaker
  • Intermediate or advanced proficiency in English preferred.
  • Ability to work collaboratively within the company.

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Remote Office
Clinician - Mandarin (Taiwan) speaker (for Central Review) - On-Demand

Clinician - Mandarin (Taiwan) speaker (for Central Review) - On-Demand

Remote Office

Job Summary

MedAvante is the clinical data sciences company that is revolutionizing drug development with smarter, faster clinical trials. The Clinician evaluates the administration of standardized structured and semi-structured diagnostic and severity assessments and provides constructive feedback to the clinicians at clinical trial sites who conduct these assessments. If you want to be part of a clinical team dedicated to unlocking new, more effective treatments and enhancing the lives of patients and those who care for them, this is an opportunity you should investigate.

Responsibilities

  • Submit accurate review of site data utilizing standardized conventions.
  • Utilize technology required to review and score site assessments.
  • Work with MedAvante Project Associates to schedule assessment reviews, submit appropriate review documentation and provide data clarification.
  • Follow Sponsor (protocol-specific) requirements and applicable Good Clinical Practices and MedAvante internal SOPs.
  • May participate in Clinical and Team meetings.
  • Participate in on-going Clinician scoring exercises and training.
  • May participate in staff meetings.
  • Responsible for keeping up to date with departmental and company communications to ensure one follows current policies, scale conventions, study procedures, and other pertinent information.

Job Requirements:

  • Minimum of a Master’s degree conferred by a clinically-focused program in a mental health discipline such as Psychology, Social Work, Counseling or Psychiatric Nursing.
  • Minimum of 2 years clinical experience diagnosing and/or treating patients with psychiatric disorder, neurocognition disorders and/or other study relevant indications.
  • 2 or more years administering study relevant standardized assessment tools and/or 2 years of working as a MedAvante clinician.

  • Proficiency with MS Word, Excel, Outlook and PowerPoint.
  • Knowledge of GCP guidelines.
  • Strong communication skills, oral and written.
  • Mandarin (Taiwan) native speaker
  • Intermediate or advanced proficiency in English preferred.
  • Ability to work collaboratively within the company.

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Hamilton, NJ
Project Coordinator

Project Coordinator

Hamilton, NJ

Job Summary

The Project Coordinator provides support for projects according to MedAvante SOPs and GCP. The successful incumbent provides quality customer service and assists in assuring that projects are delivered on time and according to client expectations.   

Responsibilities

  • Interface and provide project support as a liaison between internal departments, e.g., Project Management, Clinical Trial Services and IT and the investigative research sites and Sponsor representatives.  Support may include set-up, training, follow-up on operational questions, data management and patient safety issues (including but not limited to written and verbal communication, provision of materials and other activities related to MedAvante projects).
  • Update, track, and maintain study-specific trial management tools / systems. Set-up and maintain study files (study specific, investigator, etc.)
  • Apply knowledge of internal systems to support MedAvante clinicians, investigative sites and project activities (this may include but is not limited to managing site rater training or assessment activities.
  • Provides external customer support by determining requirements, answering inquiries, research and explore issue resolutions and escalating as appropriate, and maintaining internal issue management application.
  • Attend project team meetings and teleconferences, as well as record and distribute meeting minutes, as needed. 
  • Assist with project implementation with highest customer satisfaction.
  • Train investigative sites on MedAvante study procedures as needed.
  • Assist in the development, preparation, and delivery of project documents, e.g., study specific addendums.
  • Provide timely status reports to internal and external key stakeholders.
  • Other duties assigned by management.

Education / Qualifications:

  • University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology) or the equivalent combination of education, skills and experience to perform the job.
  • Minimum of 1 year related experience and/or training in a clinical services environment.
  • Experience working with psychiatric (e.g. depressions, anxiety) indications preferred.
  • Basic understanding of GCP.
  • Knowledge of IRB regulations and submissions (informed consent, etc.) preferred.
  • Must be proficient in native language of Hub Office and/or English.  
  • Experience / Skills
  • Ability to work in a fast-paced environment and support multiple projects concurrently and able to manage a variety of tasks.
  • Ability to work within a project team.
  • Good planning, organization and problem solving abilities.
  • Strong communication skills, oral and written.
  • Proficient in MS Office, specifically Word, Excel and Outlook.
  • Detail oriented.
  • Strong customer service skills.
  • Upholds organizational values.
  • Available for travel from 10% of the time, including overnight stays as necessary, consistent with project needs and office location.
  • Able to work flexible hours to provide support on a global basis as needed.
  • Experience with Salesforce a plus.
  • Multi-lingual a plus.

 

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Hamilton, NJ
Director, Business Development, ePro

Director, Business Development, ePro

Hamilton, NJ

Job Summary

As Director of Business Development, ePro you will be responsible for selling MedAvante’s specialized services to decision makers in pharmaceutical and biotech companies.  You will identify these decision makers and develop rapport with the objective of establishing long-term, mutually beneficial business partnerships.

Responsibilities

  • Sell MedAvante’s services to assigned potential and existing accounts.
  • Establish and has existing key contacts within the CNS pain and selected other therapeutic groups of the major pharmaceutical companies and/or biotech companies.
  • Act as the primary account management contact for selected key accounts.
  • Development and implementation of individual, territory and account strategies that incorporate significant account and industry profiling with pipeline, business development and retention strategies.
  • Contribute to market analysis on all key competitors including service offerings, acquisitions and pricing with a special focus on patient-reported outcomes vendors.
  • Contribute to proposal strategy, including pricing and service requirements.
  • Staying up-to-date with clinical trial design methodologies in the indication areas relevant to MedAvante..

Experience / Skills

Account Management Experience

  • 5-10 years of Account Management experience including experience in and in-depth knowledge of clinical trial design and drug development.
  • Sales experience in selling ePRO solutions (electronic patient-reported outcomes).
  • Experience in indication areas and clinical trials using clinical outcome measurements as endpoints (patient-reported outcomes, e.g. in pain clinical trials, respiratory, diabetes trials).
  • Track record of success in closed business metrics and quality of account relationships.

OR

Pharmaceutical Company Experience:

  • 5 or more years of experience in a pharmaceutical company, director level, from one of the following departments:
    • New Product Planning/CNS, Strategic Marketing/CNS, Global marketing
    • Involvement/input into CNS Phase II and Phase III clinical trials design/operations
    • Involvement in KOL identification and relationship building (ideally depression, schizophrenia, Alzheimer’s)
    • Previous sales experience required.
       
  • Experience interacting with senior members of pharmaceutical development organizations
  • Demonstration of the following competencies: results oriented, customer focus, excellent listening, communication, and negotiating skills, presentation skills, organization agility, business acumen, interpersonal savvy, ethics and values.

Education / Qualifications:

  • BS/BA degree
  • Advanced scientific degree strongly preferred
  • Familiar with Microsoft Outlook and Office
  • Must have or be eligible for a valid passport and driver’s license
  • Fundamental understanding of basic financial concepts

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