Senior Manager, Clinical Data Management (Oncology)
Location: Remote (Massachusetts – Virtual preferred)
Job Type: Full-time, Regular
Department: Clinical Data Management / R&D
Travel: Minimal (up to 10%)
Compensation Range: $137,000 – $215,270 (based on experience and location)
Employer: Takeda
Job ID: R0150769
Date Posted: April 25, 2025
Company Overview
Takeda is a global, R&D-driven biopharmaceutical company with 240 years of history. Its commitment to innovative medicines has made a lasting impact on patient care across the globe. Takeda values a diverse and inclusive environment where all employees’ voices are heard and innovation thrives.
Job Summary
The Senior Manager, Clinical Data Management (Oncology) is responsible for overseeing the data management activities across global development programs, ensuring high-quality data deliverables. The role involves managing vendor relationships, coordinating cross-functional teams, and ensuring data readiness for regulatory submissions.
Key Responsibilities
Lead and oversee data management activities for in-house and outsourced studies.
Ensure data-related deliverables meet expectations, particularly for key decision points and regulatory submissions.
Collaborate with internal and external stakeholders to mitigate risks and resolve issues.
Manage clinical trial data collection setup, review, and database lock processes.
Maintain high standards for data integrity and compliance with ICH-GCP and FDA regulations.
Oversee and manage external data management budgets and timelines.
Represent Takeda at external professional initiatives and organizations like SCDM, CDISC, and DIA.
Contribute to process improvements and continuous improvement initiatives in data management.
Required Qualifications
Education: BS/BA required (preferably in life sciences or technology-related fields).
Experience: 6+ years of experience in data management or drug development, with expertise in managing large drug development programs.
Skills:
Strong project management skills.
Experience with clinical trial documents and data management best practices.
Expert knowledge of FDA and ICH regulations.
Preferred Skills
Expertise in oncology and/or multiple therapeutic areas.
Experience with NDA/CTD submissions and managing data across all phases of development.
Ability to handle multiple projects simultaneously and manage vendor partnerships.
Compensation & Benefits
Base salary: $137,000 – $215,270
Short- and long-term incentives
Comprehensive health coverage (medical, dental, vision)
401(k) with company match
Paid vacation (up to 120 hours/year), sick time (up to 80 hours/year), and holidays
Tuition reimbursement, wellness programs, and volunteer time off
Workplace & Equal Opportunity
Classified as a remote position in accordance with Takeda’s Hybrid and Remote Work policy
Takeda is committed to creating a diverse workforce and providing equal employment opportunities to all employees without discrimination
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