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eCOA Licensing and Translations Manager

Company: IQVIA
Location: Durham
Posted on: January 17, 2020

Job Description:

IQVIA is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

Primarily responsible for eCOA assessment licensing and eCOA study / assessment translations. Acts as point of contact (POC) for eCOA licensing and translations related activities.

  • eCOA licensing:

    • Build relationships with assessment authors and gain solid insights on licensing and translations requirements for their assessments.
    • Collaborate globally with eCOA assessment authors, owners and licensed providers to get required agreements to develop assessments in IQVIA eCOA library and sponsor studies. Lead or contribute to assessment design reviews and approvals from assessment authors, library partners, sponsors and other relevant stakeholders.
    • Negotiate eCOA licensing costs when reasonable, especially for eCOA Library. Receive relevant COAs from authors and ensure versions and language matches study requirements.
    • Participate in proposal development for eCOA licensing.
    • In coordination with eCOA Project Manager, manage eCOA licensing project budgets and approval of invoices.
    • Develop and maintain internal database of eCOA licensing requests
    • Regularly identify COA assessments to develop in IQVIA eCOA library.

      • eCOA translations:

        • Collaborate with eCOA Study Designers and PMs to identify languages required in a study and update relevant translations tracking tool.
        • In coordination with eCOA Project Manager, manage eCOA licensing project budgets and approval of invoices.
        • Coordinate translations processes with translating agency POC including discussions on relevant eCOA system features and functionalities, project timelines, send and receive translations files, screenshots and any other related documents.
        • Ensure certificates of translations are available for assigned studies.
        • Ensure timely updates of translations tracking tool for each assigned project.
        • Learn and collate specific requirements of various regulatory authorities for screenshot submissions and other relevant documents.
        • Collate and provide feedback on translation agency to relevant IQVIA teams.

          • Licensing and translations SME:

            • Contribute towards process development and improvement in relevant business processes.
            • Ensure study timelines and deliverables related to eCOA study licensing and translations are met
            • Monitor, manage, and communicate expectations and activities related to COA licensing and translations to cross-functional project teams.
            • Perform another relevant and related activities as assigned by the Line Manager.

              • Qualifications
              • Bachelor's degree in life sciences or related field and 5 years clinical research experience including 2 years project management experience and experience in functions like eCOA, clinical operations, clinical data management, epidemiology, medical writing; or equivalent combination of education, training and experience.
              • Skills
              • Good planning, time management and prioritization skills
              • Excellent customer service skills
              • Good problem-solving skills
              • Strong communication and interpersonal skills, including good command of English language
              • Able to think and develop initiatives independently in alignment with the expectations of usual Project Management approaches
              • Strong software and computer skills, including MS Office applications, EDC, eCOA or other clinical trial systems
              • Ability to establish and maintain effective working relationships with coworkers, partners and sponsors

                Join Us

                Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

                Forge a career with greater purpose, make an impact, and never stop learning.

                IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

                IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIAs Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.

Keywords: IQVIA, Durham , eCOA Licensing and Translations Manager, Executive , Durham, North Carolina

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