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Clinician - Mandarin speaker (Shanghai) - On-Demand

Clinician - Mandarin speaker (Shanghai) - 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.
  • Mandarin native speaker and able to understand local dialect spoken in the Shanghai region
  • Intermediate or advanced proficiency in English preferred.
  • Ability to work collaboratively within the company.

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Japan
Clinical Scientist

Clinical Scientist

Japan

Job Summary

The Clinical Scientist supports projects from a clinical perspective across therapeutic areas in conjunction with project management. Additionally, the Clinical Scientist is responsible for site rater training and the training and calibration of the MedAvante clinicians.  This individual will have experience conducting assessments in CNS clinical trials as well as interacting with investigative sites and study sponsors.

This position is home-based in Japan.

Responsibilities:

  • External facing clinical representative responsible for the independent clinical management of large, international clinical trials.
  • Liaise with sponsors and sites.
  • Resolve assessment results inquiries raised by sites by working with Project Managers, and Director of Clinical Trial Services as necessary.
  • Interact with sponsors on rater qualifications/CV review.
  • Attend internal and external project meetings (e.g., weekly external client call, Investigators’ Meetings). 
  • Review and monitor study level metrics; present study dashboards to sponsors as necessary.
  • Determine and inform appropriate Clinical Trial Services staff of study requirements (resource and training needs) while managing project specific rater resource requirements based upon projections.
  • Ensure clinical quality standards are met by monitoring internal clinician and team level performance across studies and scales and resolve clinical quality or training related issues, as directed by the Director, Clinical Trial Services.
  • Ensure calibration of clinical team members and conduct rater training events as specified in Training plans.
  • Provide clinical consultation to MedAvante Clinicians and site raters
  • Participate in the process of adding and removing clinicians from a study and ensuring they are assigned within designated timeframes.
  • Work with the Director, Clinical Trial Services to develop and revise Training plans as needed.
  • Communicate with other departments (e.g., Project Management) to meet project   objectives. Coordinate resources and develop materials for Investigator Meetings.
  • Assist with or responsible for the development of project deliverables (e.g., scale verification, electronic form development, training materials for in-person or online training, etc.)
  • Work with Business Development to review potential studies, RFPs, etc.
  • Work with Marketing to support site initiatives.
  • Develop and oversee implementation of external site rater training.
  • Maintain calibration on relevant clinical scales.
  • 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.
  • Manage various project specific budget tasks/activities.
  • May require domestic and international travel.
  • Perform other job duties as determined by management.

Education / Qualifications:

  • Graduate degree in psychology, social work, counseling, psychiatric nursing or related field.
  • Minimum 4 years’ experience administering psychiatric symptom rating scales and/or Neurocognition scales, experience with structured diagnostic interviews preferred.
  • Minimum 3 years’ experience in a clinical trial or research setting or other clinical setting preferred.
  • Fluent in English, bi-lingual or multi-lingual skills are preferred.
  • Basic understanding of GCP.
  • Proficiency with MS Word, Excel, Outlook and PowerPoint.
  • Ability to travel as required.

Experience / Skills
 

  • Native Japanese speaker
  • Ability to function effectively in a fast paced environment and manage multiple projects simultaneously.
  • Demonstrate leadership skills
  • Strong problem solving/decision making skills.
  • Proven project management experience at an intermediate level.
  • 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.
  • Proficient knowledge of MS Office, specifically Word, Excel, PowerPoint and the ability to produce detailed reports and presentations using these tools.

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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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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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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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