Clinical Study Manager
Takeda
- Boston, Massachusetts, United States
- Boston, Massachusetts, United States
À propos
Job Description: Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Clinical Study Manager based remotely reporting to the Clinical Operations Leadership team. Takeda is transforming the pharmaceutical industry through our R&D-driven market leadership and a values-led culture. We offer stimulating careers and foster an inclusive, collaborative workplace with a commitment to Better Health and a Brighter Future.
Responsibilities
Lead study operational strategy and planning and oversee the execution of clinical studies for assigned clinical program(s), supporting clinical strategy defined in the Clinical Development Plan.
Collaborate with Clinical Operations Program Lead(s) to oversee execution of studies in assigned programs in compliance with quality standards (ICH GCP, local regulations, Takeda SOPs), on schedule and on budget.
Oversee strategic partners and/or CROs and other third-party vendors to meet Takeda’s obligations described in ICH-GCP and Takeda’s business objectives.
Manage studies that may vary in complexity and may include multiple studies or programs.
Ensure study issues are addressed and resolved rapidly with oversight and guidance to strategic partners/CROs.
Oversee study budgets, enrollment, and external spend; collaborate with Clinical Operations Program Leaders, Global Program Management, and Finance to monitor budgets and timelines; communicate study status, costs, and issues; escalate as needed.
Oversee vendor selection, budget and contract negotiation, and supervision of performance for activities assigned to partners; escalate issues to governance when warranted.
Review and approve key monitoring documents/plans, study plans, and conduct regular meetings; monitor protocol deviations and identify trends; document issues, risks, and mitigation strategies at the study level.
Coordinate with data management to ensure database timelines align with strategy and the plan for database lock and CSR; ensure studies are inspection-ready and support regulatory inspections if applicable.
Education and Experience
BS/BA required, preferably in a health-related, life science, or technology-related field; or equivalent experience.
Advanced degree(s) may be considered to supplement experience.
5+ years’ experience in pharmaceutical industry and/or clinical research organization, including 3+ years in clinical study management/oversight, with significant study management support experience.
Experience with early phase studies or Phase 2/3, including global/international studies; experience in more than one therapeutic area is advantageous.
Knowledge of global regulatory and compliance requirements for clinical research (e.g., US CFR, EU CTD, ICH GCP) and awareness of local country requirements.
Demonstrated project/program management and matrix leadership skills; good communication, teamwork, organizational, interpersonal, and problem-solving abilities.
Fluent business English (oral and written).
Compensation and Benefits 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.
Location: Massachusetts - Virtual
U.S. Base Salary Range: $99,500.00 - $156,420.00
The actual base salary offered depends on qualifications, experience, skills, education, and location. Benefits may include incentives, medical/dental/vision, 401(k) with company match, disability coverage, life insurance, tuition reimbursement, paid time off, and well-being benefits.
U.S. based employees may be eligible for short-term and/or long-term incentives and other benefits including sick leave and vacation accrual as applicable by location and policy.
EEO Statement Takeda is committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, marital status, veteran status, or other protected characteristics in accordance with applicable laws.
Job Details Locations: Massachusetts - Virtual
Worker Type: Employee
Worker Sub-Type: Regular
Time Type: Full Time
Job Exempt: Yes
Note: Massachusetts law prohibits the use of lie detector tests for employment decisions.
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Compétences linguistiques
- English
Avis aux utilisateurs
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