Lead Clinical Study Manager (Lead CSM)

Takeda; United States; Remote; USD 116,000 - 182,000; Full time

Job summary

Takeda is seeking a Lead Clinical Study Manager to lead study strategy and oversee execution of clinical trials remotely from Massachusetts, reporting to the Clinical Operations Leadership team.

The role collaborates with Clinical Operations leads, CROs, and strategic partners to ensure studies meet ICH-GCP standards, stay on schedule and on budget, and remain inspection-ready throughout development and regulatory processes. Fluent business English is required.

Qualifications

• BS/BA in health-related, life sciences, or tech field.
• Advanced degrees may supplement experience.
• 6+ years in pharma/ CRO with 4+ years in clinical study management.
• Knowledge of US CFR, EU CTD, ICH GCP; awareness of local requirements.
• Strong project management, leadership, and communication skills.
• Fluent business English (oral and written).

Responsibilities

• Lead study operational strategy and oversee execution for assigned trials.
• Oversee CROs/partners to meet ICH-GCP and Takeda objectives.
• Plan and manage study budgets and external spend with finance.
• Ensure studies are inspection-ready and coordinate regulatory inspections.
• Mentor junior Clinical Study Managers and support COPL as needed.
• Collaborate with data management to align timelines for CSR.

Skills

Leadership

Project management

Clinical trial management

Regulatory knowledge

Communication skills

Team collaboration

English fluency

Education

BS/BA in health-related field

Advanced degree considered

Job description

Job Description

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. 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:

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.

• 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:

• 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.

This position is currently classified as “remote” in accordance with Takeda’s Hybrid and Remote Work policy

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 - Virtual

U.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.

• U.S. based employees may be eligible for short-term and/ or long-term incentives.
• U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
• U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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.

Locations

Massachusetts - Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

It 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.