New · posted Oct 31
Takeda · Pharmaceuticals
Lead Clinical Study Manager
- Remote, Massachusetts
- Remote
- 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 Lead Clinical Study Manager based remotely reporting to the Clinical Operations Leadership team.
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. 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
Lead study operational strategy and planning and oversee execution of clinical studies for an assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan. In close collaboration with Clinical Operations Program Lead(s):
- Oversee the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget.
- Oversee Strategic Partners and/or other CROs and other 3rd party vendors to meet Takeda’s obligations described in ICH-GCP and Takeda’s business objectives.
The assigned clinical studies may be high complexity and/or high risk, e.g. multiple indications, data safety monitoring boards and/or endpoint review committees, interim analyses, requiring the coordination of multiple vendors, or other special assessments. More than one study and/or more than one program may be assigned.
What you need
- BS/BA required preferably in a health-related, life science area or technology-related fields or equivalent combination of education, training and experience.
- Advanced degree(s) (e.g., Master or Doctorate) and relevant training or experience (e.g., fellowship. internships, etc.) may be considered to supplement experience requirements.
- 6+ years’ experience in pharmaceutical industry and/or clinical research organization, including 4+ years clinical study management/oversight. Experience must include either early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs. Experience in more than one therapeutic area is advantageous.
- Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required.
- Demonstrated excellence in project/program management and matrix leadership.
- Excellent communication skills.
- Excellent teamwork, organizational, interpersonal, and problem-solving skills.
- Fluent business English (oral and written).
TRAVEL REQUIREMENTS:
- Requires approximately 5-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel.
ACCOUNTABILITIES
- Accountable for planning and operational strategy and execution for assigned clinical trials.
- Provides subject matter expertise and operational input into protocol synopsis, final protocol and other study related documents.
- Challenges study team to ensure operational feasibility, inclusive of patient and site burden
- Validates budget and ensures impacts are adequately addressed.
- Participates in country and site feasibility/selection process, with a focus on providing country insights, corporate alignment and therapeutic expertise to ensure alignment between study execution plan and program strategy.
- Challenges study team to ensure timelines meet the needs of the clinical development plan.
- Ensure new team members and vendors are appropriately onboarded.
- During Early Engagement with Strategic Partner(s) and/or other CROs, lead the development of the Operational Strategy in preparation for Operational Strategy Review; focus on ensuring accurate assumptions are applied and robust risk management plans are in place.
- Provide oversight/support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly.
- Responsible for study budget planning and management and accountable for external spend related to study execution. Works closely with Clinical Operations Program Leader(s), Global Program Management, and Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate; Communicates study status, cost and issues to Clinical Operations Program Lead(s); serve as escalation point for third party vendors managed by Strategic Partner and/or other CROs.
- Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted.
- Specific areas of sponsor oversight include, but are not limited to:
- Review and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to monitoring
- Review and endorsement of relevant study plans, as applicable
- Study team meeting management and attendance when necessary; regular review of meeting agendas and minutes
- Review of outcomes/actions related to protocol deviations review; primary purpose of review is to support the identification of trends across sites and/or the study
- Documented review and monitoring of issues, risks and decisions at the study level and implementation of appropriate mitigation strategies
- In partnership with data management, review and pressure test all database timelines and plans; ensure strong linkage between the strategy (i.e., filing/registration, data generation, etc.) with the tactical plan for database lock and CSR.
- Ensure studies are “inspection ready” at all time; may be involved in regulatory inspections by preparing for and/or attending the inspections.
- Represent the Lead Clinical Study Manager role in functional initiatives or working groups.
- Help with onboarding and mentoring of new or junior CSMs.
- May assist the program COPL in his/her role, as required
Pay
$116,000 – $182,270 a year
Employer providedU.S. Base Salary Range
$116,000.00 - $182,270.00
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.
Working conditions
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
From the posting
About Takeda
For Location
Massachusetts - Virtual
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 8% below the US median for Clinical Trial Management roles at this level.
This roleEmployer provided
Manager roles in Massachusetts6 roles publishing pay
Manager roles in the US26 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $116,000 | — | $182,270 |
| Massachusetts (middle half) | $155,500 | $175,000 | $176,500 |
| All US (middle half) | $150,000 | $162,000 | $175,000 |
This role: Takeda's own published range. Comparisons: the base pay employers published on open Clinical Trial Management roles at the same level on Regulatory Jobs, October 31, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Trial Management
The general path across 33 open Clinical Trial Management roles on Regulatory Jobs, with the titles they carry most. Not Takeda's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 28 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Clinical trial conduct14
- Collaboration and leadership14
- GMP and compliance4
- Documentation and SOPs3
- Lab testing and methods1
- Investigations and CAPA1
- Validation and qualification1
- Regulatory submissions1
- Quality systems and risk1
- Data and digital systems1
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.
- 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
- FDAeCTD(official source, opens in a new tab)The electronic Common Technical Document format for submissions
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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Lead Clinical Study Manager at Takeda
Open until filled. $116K–$182K a year, employer provided.