Principal / Sr Manager, Clinical Data Management
Treeline Biosciences•Watertown, MA
•$180,627 - $208,400•Onsite
About The Position
The Senior Manager, Clinical Data Management oversees clinical trial data management from startup through database lock, ensuring high-quality, reliable clinical data in support of development programs under the supervision of the Director of Clinical Data Science. This role provides operational leadership across studies, drives data management strategy, manages external vendors, and contributes to process optimization and inspection readiness activities.
Requirements
- Bachelor’s degree in a scientific, healthcare, or related field.
- 8+ years of clinical data management experience within the pharmaceutical or biotechnology industry.
- Prior experience independently leading data management activities across multiple clinical trials and/or programs.
- Strong understanding of clinical trial processes, clinical data standards, GCP, ICH guidelines, and regulatory expectations.
- Hands-on experience with EDC systems, clinical databases, and related clinical technologies.
- Experience managing CROs and external vendors, including oversight of deliverables, timelines, and quality.
- Excellent organizational, communication, and cross-functional collaboration skills.
- Ability to proactively identify issues, drive solutions, and escalate risks appropriately.
- Demonstrated ability to work independently in a fast-paced, collaborative biotech environment.
- High level of professionalism, ethical integrity, and commitment to improving outcomes for patients.
Nice To Haves
- Experience in Oncology clinical development strongly preferred.
Responsibilities
- Lead and oversee data management activities for assigned clinical trials and programs from study startup through database lock.
- Partner with CROs and vendors to develop and review Data Management Plans, CRF Completion Guidelines, CRF design, database and edit check specifications, database build and validation, data review plans, data transfer specifications, and database lock activities.
- Oversee electronic data capture (EDC) systems and ensure data integrity, consistency, and quality throughout the clinical trial lifecycle.
- Manage and oversee external clinical data management vendors and CRO partners, including performance oversight, issue escalation, quality expectations, timelines, and budget considerations. Provide input into vendor selection and governance processes.
- Lead data review and cleaning activities, including query management, reconciliation activities, external data integration, and risk identification.
- Collaborate closely with Clinical Operations, Biostatistics, Statistical Programming, Clinical Development, Medical Monitoring, Safety, and Regulatory teams to resolve data-related issues and support study deliverables.
- In collaboration with cross-functional clinical trial team members, drive data management strategies to ensure alignment with overall clinical development goals and program timelines.
- Develop, maintain, and improve SOPs, templates, guidance documents, and operational best practices related to clinical data management.
- Identify operational risks and implement mitigation strategies to ensure inspection readiness and compliance with GCP, ICH, and applicable regulatory requirements.
- Support process improvement initiatives and contribute to the development of scalable, efficient data management operations as the organization grows.
- Mentor junior team members and contribute to building data management capabilities across the organization.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
