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Job DescriptionAre 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.
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
EDUCATION AND EXPERIENCE:
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.
Takeda Compensation and Benefits Summary
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.
For Location:
Massachusetts - VirtualU.S. Base Salary Range:
$116,000.00 - $182,270.00The 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.
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.
LocationsMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob 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.Skills Required
- Bachelor’s degree in a health-related, life science, or technology-related field, or equivalent education, training, and experience
- 6+ years of experience in the pharmaceutical industry and/or clinical research organization
- 4+ years of clinical study management or oversight experience
- Experience with early-phase clinical studies or Phase 2 and 3 studies
- Experience with global or international studies or programs
- Knowledge of global regulatory and compliance requirements for clinical research, including US CFR, EU CTD, and ICH GCP
- Awareness of local country clinical research requirements
- Demonstrated project or program management and matrix leadership skills
- Excellent communication, teamwork, organizational, interpersonal, and problem-solving skills
- Fluent business English, oral and written
- Advanced degree or relevant training and experience
- Experience in more than one therapeutic area
Takeda Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Takeda and has not been reviewed or approved by Takeda.
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Retirement Support — Employer-funded retirement is described as notably strong, combining a dollar-for-dollar 401(k) match with an additional company contribution that scales with age and service. Access to an employee stock purchase plan further supports long-term wealth building.
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Parental & Family Support — Paid bonding leave for all parents, substantial adoption/surrogacy reimbursement, and robust caregiver resources (backup care and Maven family-forming support) are emphasized as core strengths. These offerings create a comprehensive safety net for a range of family situations.
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Healthcare Strength — Multiple medical plan options (nationwide PPO/HSA and regional HMOs), employer HSA funding, and integrated mental-health and well-being programs signal depth in coverage. Preventive care is covered in-network, and plan choices by state expand access.
Takeda Insights
What We Do
For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation, and as a future-focused organization, we’re continuing to drive forward with endurance in our steadfast pursuit to achieve the best outcomes for our patients in a rapidly changing world. We have been preparing for this period of value creation by investing in data, digital and technology, and we’re proud of our employees and their commitment to turning groundbreaking ideas into life-changing impacts. Since our founding in Japan, integrity and putting patients first have been at the heart of our identity, and we will emerge ready for our future as one of the most trusted and science-driven digital biopharmaceutical companies. Join a team where your innovation impacts lives. Together, we’ll realize improved outcomes by improving data quality, enhancing launch execution and improving the patient journey. You’ll play a critical role in accelerating data collection and increasing accuracy across all parts of the business. Patients across the globe will benefit from access to treatments afforded by greater opportunities and efficiency in our research and development.
Why Work With Us
We connect to our history and Japanese heritage through everything we do to bring our purpose, values, vision, and imperatives to life. We are committed to bringing better health and a brighter future to patients. Being a part of Takeda means having the opportunity to be a part of something bigger than yourself.
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