Lead Clinical Study Manager
Company: Takeda
Location: Remote
Job ID: R0162221
Posted On: 24 November 2025
Job Level: Senior
Travel: Minimal
About Takeda
For over 240 years, Takeda has advanced transformative science to deliver breakthrough medicines that improve patient outcomes worldwide. Today, the company remains a global leader in research-driven innovation, operating with a values-driven culture that prioritizes integrity, collaboration, and patient-centricity.
Within Takeda R&D, you will join highly skilled teams dedicated to accelerating a rich pipeline of therapies. The environment encourages diverse perspectives, scientific excellence, and continuous learning. This role offers an opportunity to meaningfully contribute to Takeda’s mission of delivering Better Health and a Brighter Future.
Position Overview
The Lead Clinical Study Manager is responsible for planning, leading and overseeing operational strategy and execution of global clinical studies across assigned programs. Working closely with Clinical Operations Program Leads, this role ensures delivery of clinical trials in accordance with ICH GCP, regulatory requirements, Takeda SOPs, timelines, and budgets.
Studies under this role may involve high complexity, multiple indications, interim analyses, external committees, global vendors, and cross-functional coordination.
Key Responsibilities
Study Strategy and Oversight
Lead operational planning and strategy for assigned clinical trials.
Provide expert input into protocol synopsis, full protocols, and core study documents.
Ensure operational feasibility with a focus on site burden, patient impact, resources, and timelines.
Validate study budgets and ensure alignment with program-level financial plans.
Study Execution and Quality
Oversee end-to-end clinical study execution, ensuring quality, regulatory compliance, and timeline adherence.
Ensure studies remain inspection-ready at all times.
Support regulatory inspection preparation and participation when required.
Review monitoring plans, outputs, risk management plans, and protocol deviation trends.
Vendor and CRO Management
Lead early engagement, operational strategy reviews, and risk planning with Strategic Partners/CROs.
Oversee vendor selection, contract negotiation, performance management, and issue escalation.
Ensure proper onboarding and alignment of third-party partners with program goals.
Budget, Risk, and Performance Management
Accountable for complete study budget planning, forecasting, and external cost management.
Work closely with Program Leads, Global Program Management, and Finance to ensure accurate budget-to-actual tracking.
Anticipate risks, resolve operational issues rapidly, and implement mitigation strategies.
Cross-Functional Leadership
Lead collaboration with data management to validate database timelines, lock strategy, and CSR deliverables.
Participate in country and site feasibility assessments to support optimal site selection.
Represent the function in internal initiatives, process improvement activities, and working groups.
Mentor and support onboarding for new or junior Clinical Study Managers.
Required Qualifications
Education
Bachelor’s degree in life sciences, health sciences, technology, or related fields.
Advanced degrees (Master’s, Doctorate) or equivalent professional training are preferred.
Experience
Minimum 6+ years in the pharmaceutical or clinical research industry.
At least 4+ years of direct experience in global clinical study management or oversight.
Experience managing Phase 1, Phase 2, or Phase 3 clinical trials.
Exposure to multiple therapeutic areas is an advantage.
Technical Expertise
Comprehensive understanding of global regulatory standards including US CFR, EU CTD, and ICH GCP.
Strong project management and matrix leadership capabilities.
Experience coordinating global studies, interim analyses, DSMBs, endpoint committees, and multi-vendor environments.
Soft Skills
Excellent communication, problem-solving, and organizational abilities.
Ability to manage complex cross-functional interactions and timelines.
Fluent business-level English.
Travel Requirements
Approximately 5–20 percent travel, including domestic and international meetings with Takeda teams, strategic partners, and external stakeholders.
Compensation and Benefits (U.S.)
For candidates based in Massachusetts – Virtual:
Base Salary Range: USD 111,800 – 175,670
Actual compensation may vary based on qualifications, experience, skills, and geographic location.
Benefits may include health insurance (medical, dental, vision), 401(k) with company match, disability coverage, life insurance, tuition assistance, paid vacation, sick time, volunteer time off, company holidays, and well-being benefits.
Equal Employment Opportunity Statement
Takeda is committed to fostering a diverse and inclusive workplace. All qualified applicants will receive consideration without regard to race, color, religion, sex, national origin, age, disability, gender identity, veteran status, or any legally protected characteristic.
How to Apply
Interested applicants may submit their application via the official Takeda careers portal by selecting the Apply Now option.
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