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Japan
Customer Support Specialist I

Customer Support Specialist I

Japan

Job Summary

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

This position is based in our office in Tokyo, Japan.

The working hours are 12:00 to 20.00.

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.
  • Fluency in Japanese and English.
  • Familiar with business conventions and cultural characteristics of mainland China
  • 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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Remote Office
Clinician - Arabic speaker (for Central Review) - On-Demand

Clinician - Arabic 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, RBANS)

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

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Hamilton, NJ
Quality Control & Assurance Analyst

Quality Control & Assurance Analyst

Hamilton, NJ

MedAvante-ProPhase, Inc., a subsidiary of WIRB-Copernicus Group was founded in 2002 with the goal of helping to bring better drug therapies to market through smarter, faster clinical trials. With this goal in mind, MedAvante-ProPhase set out to solve one of Pharma’s most intractable problems: the bias and variability that cause failed or inconclusive trials for Central Nervous System (CNS) therapies. A few years later, MedAvante-ProPhase experts pioneered Central Ratings and introduced the concept of Central Review utilizing their groundbreaking Virgil eSource solution.

Position Summary:

The Quality Control and Assurance Analyst will establish and maintain quality assurance standards and measures throughout the organization that comply with regulatory requirements and standards.  This position is responsible for working with senior leadership to assure that the company is compliant with all industry standards for quality assurance and computer system validation.

Essential Duties/Responsibilities:

  • Create, review, and update SOPs based on operational/technical needs.
  • Work with senior leadership and department heads to identify any needs for new SOPs.
  • Develop training and evaluation for staff on SOPs.
  • Cultivate and disseminate knowledge of quality assurance best practices.
  • Conduct investigations of potential data quality and/or data integrity issues (CAPA).
  • Ensures that applicable computerized systems remain in a validated, 21 CFR part 11 compliant status.
  • Assist in the development of change control processes, practices, and guidelines for new and existing technologies.
  • Plan annual internal and vendor audit schedules, conduct audits and complete audit reports.
  • Lead and prepare all aspects of external audits, providing auditors with all necessary documentation.
  • Identify external audit requirements and mitigate any company risks to compliance.
  • Provide support for internal and external audits, corrective actions, responses and follow-up.

Travel Requirements:

  • Must be able to travel at least 30%; this will include travel between the Hamilton, NJ and New York, NY offices.

Qualifications/Experience Requirements:

  • Five (5) years industry related experience, including at least four (4) years’ experience with Good Clinical Practice (GCP) auditing in the pharmaceutical/clinical research industry
  • Must have a minimum of three (3) years of quality assurance with evidence of increasing responsibility.
  • Practical knowledge of federal regulations governing human subject research (21 CFR Parts 11) and guidelines for Good Clinical Practice (ICH GCP) required.
  • Must have familiarity and experience with FDA audit preparation and hosting as well as familiarity with standards and processes for electronic system validation.
  • Experience with developing CAPA reports preferred. 
  • Experience with study design and research best practices is required. 
  • Strong communication (written and oral), organization and interpersonal skills and the ability to interact with staff, sponsors, and regulatory agencies needed.
  • Proficiency with learning management systems (Compliance Wire a plus) as well as with MS Windows, MSWord, MS Excel, MS PowerPoint, and MS Access.

Education / Certifications Requirements

  • Bachelor’s degree in a relevant discipline required; or equivalent combination of education and experience
  • Certifications for quality professionals through the Society for Quality Assurance and the American Society for Quality or comparable certifications are desirable.

We encourage you to visit us at www.medavante.com to learn more about our organization.  

We are an Equal Opportunity Employer.  Minorities, females, veterans and members with disabilities are encouraged to apply.  

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Japan
Project Coordinator

Project Coordinator

Japan

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.   

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

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 Japanese and 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.

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

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Remote Office
Manager Clinical Trial Services

Manager Clinical Trial Services

Remote Office

Job Summary:

The Clinical Manager, Clinical Trial Services is responsible for managing a clinician cohort, overseeing the coordination and monitoring of training and calibration activities as well as other operational support within the Clinical Trial Services Department.

These responsibilities include co-developing and implementing training and calibration (T&C) activities, ensuring quality control measures are implemented, analyzing reports, reporting on status of related CTS projects, developing process efficiencies, and managing contractor invoices.

The position can be home-based, however an overlap with CET business hours is necessary.

Responsibilities:

  • Manage direct reports according to company policy (including, but not limited to, the monitoring of performance, setting goals and objectives and writing performance reviews).
  • Provide input to Clinical Scientists on individual training and performance plans.
  • Collaborate with the Director, CTS and the Senior Manager, CTS Se to ensure optimal clinician utilization, projections, and coverage of assessment needs across studies.
  • Manage timesheet reviews, paid time-off approval, and IT challenges which may impact clinicians.
  • Participate in clinician recruitment process.
  • Meet resource and operational requirements as specified by projects from various departments that relate to the Clinical Trial Services Department.
  • Oversee operational implementation of T&C plan requirements and monitor progress.
  • Ensure that training and calibration occurs within timeframes.
  • Implement and monitor quality control measures to ensure compliance in meeting T&C plans.
  • Oversee/coordinate internal QC of materials, processes and metrics related to the operational implementation of training and calibration.
  • Assist CTS team with prioritizing training needs.
  • Assist in developing and implementing departmental processes as needed.
  • Work to process Clinician payments and assist department head with budget management
  • Perform other job duties as determined by management.
  • May perform clinician duties if needed.

Education/Qualifications:

  • Graduate degree in psychology, social work, nursing, or related field.
  • 2 years Supervisory experience preferred, including interviewing and candidate selection.
  • Fluent in English, bi-lingual or multi-lingual skills are preferred. 
  • Basic understanding of GCP.
  • Proficiency with MS Word, Excel, Outlook, and PowerPoint.

Experience / Skills:

  • Ability to work collaboratively within the company.
  • Demonstrated leadership skills.
  • Excellent interpersonal skills and problem solving/decision making skills.
  • Ability to work independently.
  • Ability to deliver against set objectives.
  • Excellent organizational skills.
  • Excellent oral and written communication skills.
  • Excellent project management skills.
  • Ability to effectively manage and interact with sponsors.

Other Requirements:

May require domestic and international travel.

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Hamilton, NJ
Senior Applications Developer

Senior Applications Developer

Hamilton, NJ

Job Summary

The Senior Applications Developer is responsible for developing high quality web, mobile and client server applications, while supporting existing applications with enhancing application design, features and functions, troubleshooting end systems issues and applying bug fixes.

Senior Developers will work closely with the functional resources to ensure that applications are fulfilling client's business requirements. Activities will include all aspects of development lifecycles (e.g. analysis, design, development, test, etc.).

This role will be responsible for ensuring application development standards are adhered to, both for their own development and that of application developers and associate application developers within their immediate group. This individual may also need to help oversee day-to-day activities of an offshore production development/support team.

Responsibilities

  • Assist the Solution Architect in leading the analysis, design, development and test activities for Application Development.
  • Implement and mentor the software development team in using best practices for application development.
  • Provide leadership to the development team in meeting project deliverables with quality and consistency.
  • Assist in the preparation and documentation of software requirements and specifications.
  • Clarify and drive team goals on a technical level making sure that the solutions proposed and designed are in line with the department and organization vision while maintaining architectural integrity.
  • Provide technical support with existing legacy applications and databases as needed.
  • Actively contribute to the technical design and implementation.
  • Coding, unit testing, user acceptance testing, bug fixes, deployment activities.
  • Investigate new technologies and approaches to address business needs and improve existing systems.

Education and Experience

  • BS/Master’s degree or equivalent in Computer Science or Software Engineering
  • 7+ years of experience developing Web/Mobile/Desktop applications
  • Working technical knowledge of object-oriented programming languages, primarily C#
  • Experience in developing Native or Hybrid mobile apps for iOS and Android platforms, using tools such as Xamarin
  • Strong experience developing Restful Web Services and API based development
  • Experience with Cloud based application development such as AWS, Microsoft Azure
  • Extensive experience with SQL programing
  • Extensive experience with JS Frameworks such as AngularJS, Node.js or any others
  • Experience with specific phases of the software development life cycle, especially Agile (SCRUM) and Test Driven Development
  • Strong experience designing and working with Service Oriented architecture as well as n-tier architectures
  • Experience developing solutions for use in the pharmaceutical industry (including clinical trials) would be a plus.

Knowledge, Skills and Abilities

  • Strong understanding of Agile development principles
  • Good understanding of SOLID Design principles
  • Flexible and adaptable in regards to learning and understanding new technologies
  • 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, Xamarin
  • Expertise in developing Web/Mobile/Desktop applications
  • Expertise with unit testing and using unit testing frameworks such as NUnit
  • Highly self-motivated and directed
  • Proven analytical and problem-solving abilities
  • Strong written and verbal communication skills including a very strong ability to collaborate by phone and email
  • Ability to work both independently and in a team-oriented, collaborative environment

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

Clinician - Japanese 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.
  • Japanese 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 Senior Project Coordinator provides support and acts as the lead for staff within the Logistics department according to MedAvante SOPs and Sponsor plans, as needed. The Sr. Project Coordinator is the point person for the Logistics department and interfaces between other departments to ensure that there is a seamless assimilation of services.

 

Responsibilities

  • Interface with internal departments, such as Project Management and Clinical Trial Services to ensure procedures are implemented and followed appropriately by the Logistics team.
  • 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).
  • Interact with internal work groups to assist with evaluating project resource needs, processes and timelines as needed.
  • Supports manager with overseeing Logistics staff with day to day operational activities.
  • Recognizes, documents and alerts manager of trends to be addressed.
  • Recommends solutions to streamline the efficiencies of internal department processes and assists with the design and implementation of processes.
  • 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 sties 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.
  • Train staff on Logistics processes as needed (this may include internal staff in Logistics or across departments).
  • Mentor Logistics staff as needed.
  • Independently develops, prepares and delivers internal departmental documents including process related Work Instructions and Guidelines and project documents as needed.
  • Provide timely status reports to internal and external key stakeholders.
  • Review progress of projects and initiates appropriate actions to achieve target objectives.
  • 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 3 years’ 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
 

  • Is proficient with the processes of all MedAvante service offerings and internal systems.
  • Ability to work in a fast-paced environment and support multiple projects concurrently.
  • Ability to work within a project team.
  • Strong planning, organization and problem solving abilities.
  • Strong communication skills, oral and written.
  • Proficient in MS Office, specifically Word, Excel andOutlook.
  • 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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