New · posted Oct 31
Takeda · Pharmaceuticals
Senior Manager, Clinical Trial Delivery and Pharmacovigilance Documentation Excellence
- Cambridge, MA
- Hybrid
- Full-time
- Manager
The role
Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Senior Manager, Clinical Trial Delivery and Pharmacovigilance Documentation Excellence in a hybrid role reporting to the Sr. Director, Clinical Trial Delivery and Pharmacovigilance Documentation Excellence.
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 work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, 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 a necessary contributor to our inspiring, bold mission.
GOALS
- Information Management (RIM) steward. Oversee preservation of and access to archived clinical records in support of study close-out, inspection readiness, acquisitions, divestments, and records management initiatives.
- Serve as subject matter expert and execution lead for study team-facing support across the inspectable records lifecycle for complex or business-critical trials.
- Drive consistent, high-quality execution of clinical and PV records activities across the portfolio.
What you need
- Scientific or allied health/medical degree (BSc/BA) or equivalent experience.
- 6+ years of progressive experience in pharma/biotech/CRO environments with expertise in TMF/eTMF and/or PV documentation, including 2+ years collaborating with global teams, vendors, and cross-functional stakeholders.
- Strong knowledge of applicable regulations and guidance (e.g., ICH E6 (R2/R3), 21 CFR Part 11, EU CTR as applicable, and EU GVP), with demonstrated application of ALCOA+ / data integrity and Good Documentation Practices.
- Strong understanding of the CDISC TMF Reference Model, TMF plans/Expected Document Lists (EDLs), and risk-based TMF QC/health check approaches to maintain continuous inspection readiness.
- Demonstrated experience in records management programs; pharmaceutical records management experience and knowledge of related regulatory requirements preferred.
- Proven ability to work independently, take initiative, and complete tasks by established deadlines.
- Strong attention to detail, document organization, prioritization, scheduling, and deadline management skills.
- Strong communication skills and customer focus, with the ability to work effectively in a global, cross-functional organization.
- Proactively identifies continuous improvement opportunities that increase operational efficiency through process and metrics analysis.
- Applies lessons learned to continuously improve documentation management practices across study teams and share knowledge with stakeholders as needed.
- Demonstrated capability in governance, vendor management, and performance management, including SLA/KPI design, root cause analysis, CAPA oversight, and escalation management.
- Technology acumen, including hands-on familiarity with eTMF platforms, metrics, reporting/dashboards, and the ability to partner with systems/IT to optimize workflows, metadata quality, and controls; PV systems experience, such as safety databases, preferred.
- Strong communication, influencing, and negotiation skills, with the ability to drive cross-functional alignment and accountability.
ACCOUNTABILITIES
- Manage TMF and PV documentation activities across the portfolio acting as a primary point of contact for TMF/PV documentation topics with Clinical Trial Delivery, Medical and PV functions, and within R&D Quality.
- Collaborate with cross-functional representatives and external partners to promote records excellence and ensure archived clinical records remain retained and accessible in support of Takeda records management policies, clinical trial delivery, regulatory filings and submissions, acquisitions, and divestments.
- Coordinate and manage TMF processes and inspection readiness strategies in partnership with study execution teams and Clinical and PV Documentation Excellence.
- Lead end-to-end subject matter expertise and support for TMF activities related to acquisitions and divestments, including due diligence, migrations, integration, records reconciliation, quality oversight, transfer management, and study team and vendor support.
- Oversee and maintain physical records room operations, including archiving, indexing, and retrieval of critical physical records, as well as management of clinical records stored globally at Takeda external vendor off-site facilities.
- Manage and maintain electronic records in Takeda content management systems and third-party databases.
- Manage oversight and delivery for Takeda clinical records management archival vendors.
- Maintain tracking mechanisms that enable efficient identification of clinical records across systems and locations.
- Support preparation of documentation required for regulatory inspections and internal audits. May stand in front of inspector(s) during inspection(s).
- Contribute to company and department goals by leading initiatives that optimize clinical records management, improve efficiency, and advance automation, including records transfer and consolidation, divestment support, annual destruction, and retention reviews.
- Provide high-quality customer service and records support across all levels of the organization.
- Serve as the RIM steward for all TMF records
- Provide project management, oversight, and expert records guidance to study execution teams for inspection preparation, readiness checks, and backroom inspection and audit support.
- Assist with audit and Health Authority inspection responses, CAPAs and actions.
- Identify gaps and escalate risks related to TMF and PV documentation quality.
- Support implementation of SOPs, WIs, process improvements and technology enhancements
- Support onboarding, training and quality delivery of internal global capability center and external resources
Skills named in this posting
Pay
$137,000 – $215,270 a year
Employer providedU.S. Base Salary Range
$137,000.00 - $215,270.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
For information about our benefits, please click here.
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
Where you'll work
Cambridge, MAHybridOpen in Maps (opens in a new tab)
More jobs in Cambridge, MAWorking conditions
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
From the posting
About Takeda
For Location
USA - MA - Cambridge - Kendall Square - 500
Job Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Equal opportunity, accessibility and legal noticesTakeda's statements, word for word
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.
EEO Statement
Takeda 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.
Job intelligence
The context around this role
Live data · October 31, 2026
Salary intelligence
How the pay compares
This role's midpoint is 5% above the US median for Clinical Operations roles at this level.
This roleEmployer provided
Manager roles in the US6 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $137,000 | — | $215,270 |
| All US (middle half) | $164,250 | $167,500 | $170,750 |
This role: Takeda's own published range. Comparisons: the base pay employers published on open Clinical Operations roles at the same level on Regulatory Jobs, October 31, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Operations
The general path across 42 open Clinical Operations roles on Regulatory Jobs, with the titles they carry most. Not Takeda's own promotion track.
Career resources on Clinical Operations
Skills DNA
What this role leans on
How many of the posting's 36 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Documentation and SOPs25
- Collaboration and leadership11
- Clinical trial conduct9
- GMP and compliance7
- Data and digital systems3
- Regulatory submissions2
- Quality systems and risk2
- Investigations and CAPA1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- ICHICH E6 good clinical practice(official source, opens in a new tab)The international standard for the conduct of clinical trials
Company hiring pulse
Takeda on Regulatory Jobs
- 64
- Open roles
- 61
- Distinct roles
- 16
- Locations
By discipline
- Regulatory24 38%
- Clinical21 33%
- Quality18 28%
By level
- Director37 58%
- Senior & Principal12 19%
- Manager9 14%
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Senior Manager, Clinical Trial Delivery and Pharmacovigilance Documentation Excellence at Takeda
Open until filled. $137K–$215K a year, employer provided.