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Sr. Clinical Document Management Specialist

Company: Takeda Pharmaceutical
Location: Cherry Hill
Posted on: January 13, 2022

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAre you looking for a patient-focused company to inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Senior Clinical Document Management Specialist based in Lexington, MA, or remotely reporting to the Manager, Clinical Document Management.At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to accomplish their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.Here, you will be an important contributor to our inspiring, bold mission.GOALS:The Senior Clinical Document Management Specialist (CDMS) manages Trial Master File (TMF) compliance from set-up through to final archival of assigned studies, ensuring adherence to operating model(s), SOPs, and applicable clinical trial regulations.

  • Provide expertise to the Clinical Operations Manager (COM), Clinical Operations Program Lead (COPL), and Study Execution Team (SET) to provide a complete and accurate TMF through documentation quality, consistency, and process compliance across clinical trials and programs.
  • Work with CDM management to establish TMF health improvement and inspection readiness strategies.
  • Support preparation of documentation required for regulatory agency inspections and internal audits.ACCOUNTABILITIES:
    • Support TMF deliverables and oversight activities, QC planning, TMF health metrics, overall TMF lifecycle management, inspection readiness and preparation.
    • Manage overall performance of the TMF and TMF processes to ensure TMF compliance and inspection readiness across the organization, including elements outsourced to the CRO.
    • Issue escalation internally and with vendors.
    • Oversee consolidation and archive preparation of the TMF, working with CRO partners to ensure compliance with company SOPs and timelines throughout the process.
    • Support TMF inspection readiness.
    • Support periodic quality assessments of the TMF.
    • Enforce readiness of TMF documents and ensure clinical records are filed.
    • Provide education, feedback and support to Study Teams to build knowledge and awareness of good document management practices and TMF for clinical trials.
    • Independently and with direction from the CDMTS Team Lead, prepares TMF for agency inspections.
    • Work with Head of Document Management and R&D QA on logistical strategies for complex regulatory inspections.
    • Independently establish and support assigned TMF corrective action plans under the direction of CDMTS Team Lead/Manager.
    • Help prepare audit and inspection responses. Represent CDM by presenting and training on document management processes to functional departments and vendors.
    • Represent CDM by presenting and providing training on document management processes to functional departments and vendors.
    • Be a mentor for CDMTS, providing training and support around clinical document management and inspection readiness activities.
    • Lead CDM projects to enhance efficiencies in document management.
    • Manage collaboration across R&D to agree to study-specific TMF. Oversee the consolidation of the R&D TMF across departments and vendors at the end of the study.
    • May perform responsibilities (as assigned by CDM Management) supporting or acting in the role of Designated Clinical Archivist (or backup), such as archival of documents, retrieval of archived documents, tracking and monitoring of documents stored off-site, identifying archived records that have reached the minimum record retention guidelines to determine if destruction is appropriate, and other activities as assigned by CDM management.EDUCATION AND EXPERIENCE:
      • Minimum 5 years' experience in pharmaceutical industry, clinical research organization, or related role within Clinical Documentation Management space.
      • Experience with use of Electronic Document Management Systems and Electronic Trial Master File Systems, Veeva.
      • Experience in Records management/TMF management and oversight.
      • Customer focus with an ability to interact in a global organization, including issue escalation, training and responding to inquiries and concerns.
      • Knowledge of regulatory requirements and ICH/GCP guidelines for clinical trials and to support clinical records management.
      • Experience with clinical trials, regulatory submissions, regulatory agency inspection, and knowledge of document management best practices.
      • Awareness of sponsor oversight.WHAT TAKEDA CAN OFFER YOU:
        • 401(k) with company match and Annual Retirement Contribution Plan.
        • Tuition reimbursement Company match of charitable contributions.
        • Health & Wellness programs including onsite flu shots and health screenings.
        • Generous time off for vacation and the option to purchase additional vacation days.
        • Community Outreach Programs.Location and Salary Information:
          • Location(s): Cambridge/Lexington or Remote.
          • Base Salary Range: $77K-$110K based on candidate professional experience level.This posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. - 8-5-101 et seq.Empowering Our People to ShineDiscover more at takedajobs.comNo Phone Calls or Recruiters Please.EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, Cherry Hill , Sr. Clinical Document Management Specialist, Executive , Cherry Hill, New Jersey

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