DurhamRecruiter Since 2001
the smart solution for Durham jobs

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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


Implementation Manager (Bi-Lingual)
Description: About Meltwater br br Founded in Oslo in 2001 before moving our headquarters to San Francisco in 2006, Meltwater is the global leader in media intelligence, with over 2,000 employees globally and (more...)
Company: Meltwater
Location: Raleigh
Posted on: 01/29/2020

Project Manager
Description: CompuGain is an Project Manager firm providing project-based solutions,software solutions and professional staffing services. Job Description: Direct, assign responsibilities and scope of authority, and (more...)
Company: CompuGain Corporation
Location: Raleigh
Posted on: 01/29/2020

Executive Assistant to the CEO
Description: Position Summary:We are looking for an experienced, polished, bright, Executive Assistant with a positive, can do attitude to provide support to the CEO of Vontier. You will work closely with a team of (more...)
Company: Fortive Corporation
Location: Raleigh
Posted on: 01/29/2020


Project Manager
Description: Hi ALL, Greetings from SRS Consulting Inc. Please find the below job description and let me know if you are interested or if possible share this requirement with your known person who is looking for similar (more...)
Company: SRS Consulting Inc
Location: Raleigh
Posted on: 01/29/2020

Territory Sales Manager (wiring systems)
Description: Company: br br Hubbell Incorporated br br Corporate Overview br br Hubbell Incorporated was founded in 1888 and has grown into an international manufacturer of quality electrical, lighting (more...)
Company: HUBBELL
Location: Raleigh
Posted on: 01/29/2020

Customer Success Enablement Program Manager
Description: We believe work is not a place, but rather a thing you do. Our technology revolves around this core philosophy. We are relentlessly committed to helping people work and play from anywhere, on any device. (more...)
Company: Citrix Systems
Location: Raleigh
Posted on: 01/29/2020

Technical Project Manager
Description: PRIMARY RESPONSIBILITIES br br Serve as the primary subject matter expert SME for the provision of support for clinical studies utilizing Bioclinica RTSM technology by: br br Collaborating (more...)
Company: BioClinica
Location: Raleigh
Posted on: 01/29/2020

Enterprise Testing Associate- Wealth and Investment Management
Description: Job Description br Important Note: During the application process, ensure your contact information email and phone number is up to date and upload your current resume prior to submitting your application (more...)
Company: Wells Fargo Bank
Location: Raleigh
Posted on: 01/29/2020

Key Account Manager
Description: Overview br br You're ahead of the curve in market access trends and market dynamics. br br You have what it takes: a competitive drive coupled with the exceptional ability to communicate the (more...)
Company: Syneos Health Commercial Solutions
Location: Raleigh
Posted on: 01/29/2020

IT Security Architect Program Director
Description: Position: IT Security Architect Program Director Location: Raleigh NC Duration: 12 Months Interview Type: Either Webcam or In Person Required Skills: Risk Management - must be able to Identify
Company: Refulgent Technologies Inc.
Location: Raleigh
Posted on: 01/29/2020

Log In or Create An Account

Get the latest North Carolina jobs by following @recnetNC on Twitter!

Durham RSS job feeds