Lead Clinical Study Manager
Company: Takeda
Location: Remote (Massachusetts – Virtual)
Job Type: Full-Time
Employment Type: Permanent
Job Level: Senior
Category: Clinical Development / Clinical Operations
Experience Required: Minimum 6+ years
Travel Requirement: 5–20% (including international travel)
Job ID: R0174202
Date Posted: February 12, 2026
Job Overview
Takeda is seeking an experienced Lead Clinical Study Manager to support its Global Development Organization (GDO). This role is responsible for leading operational strategy, planning, and execution of clinical studies within assigned clinical programs. The position focuses on ensuring compliance with global regulatory standards, maintaining study quality, and delivering clinical trials on schedule and within budget.
The successful candidate will collaborate with cross-functional teams, strategic partners, contract research organizations (CROs), and external vendors to ensure effective clinical trial management and successful delivery of innovative therapies.
Key Responsibilities
Lead operational strategy, planning, and execution of assigned clinical trials aligned with the Clinical Development Plan.
Oversee study execution in compliance with ICH-GCP guidelines, regulatory requirements, and company standard operating procedures.
Provide operational and subject matter expertise for protocol development and study-related documentation.
Ensure operational feasibility of clinical studies, including patient and site considerations.
Manage clinical study budgets, timelines, and resource allocation.
Supervise and manage CROs, strategic partners, and third-party vendors, ensuring performance and contractual compliance.
Monitor study progress, identify risks, and implement mitigation strategies.
Support country and site feasibility assessments and site selection processes.
Ensure studies maintain inspection readiness and support regulatory inspections and audits.
Collaborate with data management teams to align database timelines, study strategies, and reporting processes.
Mentor junior clinical study managers and support team onboarding activities.
Represent clinical operations in cross-functional initiatives and process improvement programs.
Operational Accountabilities
Manage study-level risk assessments, issue resolution, and escalation procedures.
Review and approve monitoring plans, study documentation, and operational outputs.
Support protocol deviation reviews and trend identification.
Oversee vendor selection, contract negotiations, and performance evaluation.
Ensure quality assurance and compliance across all study activities.
Education Requirements
Bachelor’s degree (BS/BA) in life sciences, healthcare, technology, or a related field.
Advanced degree (Master’s or Doctorate) or equivalent training may supplement experience requirements.
Experience Requirements
Minimum 6+ years of experience in the pharmaceutical industry or clinical research organization.
At least 4+ years of experience in clinical study management or clinical trial oversight.
Experience managing early-phase or Phase II/III global clinical studies.
Experience working across multiple therapeutic areas is advantageous.
Required Skills and Competencies
Strong knowledge of global clinical research regulations including US CFR, EU CTD, and ICH-GCP guidelines.
Demonstrated project and program management expertise.
Experience managing global clinical operations and matrix teams.
Strong leadership, communication, and stakeholder management skills.
Excellent analytical, organizational, and problem-solving abilities.
Fluent business-level English communication skills.
About the Organization
Takeda is a global, research-driven biopharmaceutical organization focused on advancing innovative therapies and improving patient outcomes worldwide. Through its Global Development Organization, the company integrates data, digital technologies, and advanced analytics to accelerate clinical development and enhance trial performance. Takeda promotes a collaborative, inclusive work environment dedicated to scientific excellence, patient safety, and innovation.
Compensation and Benefits
Compensation is based on experience, qualifications, and geographic location. Eligible employees may receive performance incentives, healthcare benefits, retirement plans, paid time off, and professional development opportunities in accordance with company policies.
Equal Opportunity Statement
The organization provides equal employment opportunities and fosters a diverse and inclusive workplace aligned with applicable employment laws and regulations.
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