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 5+ years
Travel Requirement: Minimal
Job ID: R0172675
Date Posted: February 12, 2026
Job Overview
A remote opportunity is available for a Clinical Study Manager to lead operational planning and execution of clinical trials within assigned clinical programs. The role focuses on managing study operations, ensuring regulatory compliance, and supporting the delivery of high-quality clinical research aligned with clinical development strategies.
The selected candidate will collaborate with clinical operations leadership, cross-functional teams, contract research organizations (CROs), and external vendors to manage clinical study activities, timelines, budgets, and operational performance. This position supports the development and execution of low to medium complexity global clinical studies.
Key Responsibilities
Lead operational planning, strategy development, and execution of assigned clinical trials.
Ensure study activities comply with ICH-GCP guidelines, global regulatory standards, and company procedures.
Provide operational input and subject matter expertise for protocol development and study documentation.
Support feasibility assessments, site selection, and country-level study planning.
Manage study timelines, budgets, and operational deliverables.
Oversee CROs, strategic partners, and third-party vendors to ensure study performance and compliance.
Identify and manage study risks, issues, and mitigation strategies.
Ensure operational feasibility and optimize patient and site experience.
Monitor study progress and communicate status, cost, and operational issues to leadership teams.
Review monitoring plans, study outputs, and protocol deviation reports.
Collaborate with data management teams to align database planning, data generation, and reporting activities.
Maintain continuous inspection readiness and support regulatory inspections when required.
Participate in cross-functional initiatives and process improvement activities.
Operational Accountabilities
Execute study-level operational strategy aligned with the Clinical Development Plan.
Manage vendor selection, contract negotiation, and performance monitoring.
Ensure appropriate onboarding of study teams and external partners.
Monitor study metrics, risk management plans, and operational decisions.
Review study documentation, meeting outputs, and monitoring activities.
Education Requirements
Bachelor’s degree (BS/BA) in life sciences, healthcare, technology, or related discipline.
Advanced degree (Master’s or Doctorate) or relevant training may supplement experience requirements.
Experience Requirements
Minimum 5+ years of experience in the pharmaceutical industry or clinical research organization.
At least 3+ years of experience in clinical study management, clinical trial oversight, or significant study management support roles.
Experience in early-phase, Phase II, or Phase III clinical trials.
Experience managing global or international clinical studies is preferred.
Exposure to multiple therapeutic areas is advantageous.
Required Skills and Competencies
Knowledge of global clinical research regulations including US CFR, EU CTD, and ICH-GCP standards.
Strong project and program management capabilities.
Experience working in matrix environments and managing cross-functional teams.
Effective communication and stakeholder management skills.
Strong analytical, organizational, and problem-solving abilities.
Excellent teamwork and collaboration skills.
Fluent business-level English communication (written and verbal).
Compensation and Benefits
Compensation is based on qualifications, experience, and geographic location. Eligible employees may receive performance incentives, healthcare coverage, retirement benefits, paid leave, and professional development opportunities in accordance with company policies.
About the Organization
Takeda is a global research-driven biopharmaceutical organization focused on advancing innovative therapies and improving patient outcomes. Through its Global Development Organization, the company leverages advanced technologies, data analytics, and collaborative research models to accelerate clinical development and ensure patient-centric clinical trials.
Equal Opportunity Statement
The organization is committed to providing equal employment opportunities and maintaining a diverse, inclusive workplace in accordance with applicable employment laws and regulations.
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