Sr. Clinical Document Management Specialist
Company: Takeda Pharmaceutical
Location: Cherry Hill
Posted on: January 13, 2022
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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
- 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
- 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
- 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
- Lead CDM projects to enhance efficiencies in document
- 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
- 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
- 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
- Awareness of sponsor oversight.WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution
- Tuition reimbursement Company match of charitable
- Health & Wellness programs including onsite flu shots and
- 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
Keywords: Takeda Pharmaceutical, Cherry Hill , Sr. Clinical Document Management Specialist, Executive , Cherry Hill, New Jersey
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