Senior Manager, Clinical Data Management

Description

The Senior Manager, Clinical Data Management (CDM) will oversee and execute end-to-end data management activities for early- and late-phase clinical studies in a fast-paced, small-biotech environment. This role requires a blend of strategic leadership and hands-on operational responsibilities to ensure high-quality, inspection-ready clinical datasets that support program milestones, regulatory submissions, and critical decision-making.

The ideal candidate is proactive, detail-oriented, and comfortable rolling up their sleeves to perform data management tasks while also managing CROs/vendors and providing strategic oversight. Candidates with qualification/experience of one level above or below this role may also be considered.

• Serve as the CDM lead for one or more clinical programs, accountable for overall data quality, timelines, documentation, and deliverables.
• Represent Data Management in study teams, Biometrics, Clinical Operations, and Regulatory meetings.

• Provide expertise and oversight of all clinical database activities from design/start-up to closeout.
• Reviews protocols for appropriate data capture including electronic (eCRF) design.
• Support CRF design, review, and validation of clinical database.
• Provides oversight of database set-up/migrations/upgrades including coordinating and/or performing User Acceptance Testing.
• Conducts oversight of data management vendors via ongoing review of quality and performance metrics.
• Generates, resolves, and tracks data queries to ensure the integrity of the clinical data.
• Facilitates and participates in?data?cleaning activities.
• Generates and/or reviews/approves study documents.
• Responsible for maintaining internal data management timelines and metrics. Maintains study DM related documents/files for inspection readiness.
• Proactively identifies potential data management issues/risks and communicates it within the study team for further action.
• Ensure all CDM activities comply with GCP, ICH guidelines, company SOPs, and regulatory requirements.
• Contribute to development and continuous improvement of data standards, processes, and templates.
• Support audit/inspection readiness activities and respond to data-related findings.

• Bachelor’s or Master’s degree in Life Sciences, Computer Science, Statistics, or health-related field.
• 8+ years of hands-on clinical data management experience, ideally in oncology.
• Strong expertise in EDC systems (Rave, Veeva, or similar) and hands‑on database build & UAT.
• Proven track record in small biotech or fast‑paced environments with significant operational responsibility.
• Experience with vendor oversight and management of external data sources.
• Demonstrated ability to lead database locks and deliver clean, inspection‑ready datasets.
• Strong interpersonal skills, collaborative mindset, and ability to thrive in a lean, resource‑constrained organization.

• Oncology experience strongly preferred (Phase 1/2).
• Experience with programming or data visualization tools (SAS, R, Spotfire) a plus.
• Experience in implementing data standards and process optimization at small biotech.
• Prior experience supporting regulatory submissions (NDA, BLA, MAA) is an advantage.

• Hands‑on, proactive, accountable—comfortable doing the work, not just delegating.
• Ability to manage competing priorities across multiple studies.
• Strong problem‑solver with excellent attention to detail.
• Effective communicator who builds strong cross‑functional partnerships.
• Enjoys working in a nimble, entrepreneurial biotech environment.

$175k - $198k