Senior Manager, Clinical Data Management

Our Watertown based client is seeking a Senior Manager, Clinical Data Management to lead end‑to‑end clinical data management activities across our development programs. In this role, you will ensure high‑quality, reliable clinical data from study startup through database lock while providing strategic and operational leadership. You will collaborate closely with cross‑functional teams, oversee CROs and external vendors, and contribute to process optimization and inspection readiness as our organization continues to grow.

Key Responsibilities

• Lead and oversee data management activities for assigned clinical trials from study startup through database lock.
• Partner with CROs and vendors to develop and review Data Management Plans, CRF Completion Guidelines, CRF design, database/edit check specifications, data review plans, data transfer specifications, and database lock deliverables.
• Oversee EDC systems and ensure data integrity, consistency, and quality throughout the clinical trial lifecycle.
• Manage external data management vendors and CRO partners, including performance oversight, issue escalation, quality expectations, timelines, and budget considerations.
• Lead data review and cleaning activities, including query management, reconciliation, external data integration, and risk identification.
• Collaborate with Clinical Operations, Biostatistics, Statistical Programming, Clinical Development, Medical Monitoring, Safety, and Regulatory teams to resolve data‑related issues and support study deliverables.
• Drive data management strategy to ensure alignment with clinical development goals and program timelines.
• Develop, maintain, and enhance SOPs, templates, guidance documents, and best practices for clinical data management.
• Identify operational risks and implement mitigation strategies to ensure inspection readiness and compliance with GCP, ICH, and regulatory requirements.
• Support process improvement initiatives and contribute to building scalable, efficient data management operations.
• Mentor junior team members and help strengthen data management capabilities across the organization.

Required Qualifications

• Bachelor’s degree in a scientific, healthcare, or related field.
• 8+ years of clinical data management experience in the pharmaceutical or biotechnology industry.
• Proven experience independently leading data management activities across multiple clinical trials and/or programs.
• Oncology clinical development experience strongly preferred.
• 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.