Director, Clinical Data Management

Role Summary

Director of Clinical Data Management, reporting to the Sr. Director, Clinical Data Management. Responsible for all data processes related to assigned studies, overseeing data collection workflows across all data sources, ensuring quality and integrity of clinical data including CRF/edit check specifications, Data Management Plans, data systems validation and UAT, listings generation, and review of clinical data for completeness, accuracy, and compliance. Based in San Francisco, CA or Cambridge, MA with 5% travel.

Responsibilities

• Day-to-day management of vendors involved in data management, ensuring quality of deliverables and that SET timelines are met
• Gather input from stakeholders and design data flow across data sources and across vendors
• Develop and review study plans and protocols to ensure data collection designs meet study objectives (System Validation Plans, Data Management Plans, Data Transfer Plans, Data Review Plans, Data Monitoring Plans, Data Coding Guidelines)
• Develop and review specifications for database build/validation, edit checks, external system integration, or other data-related systems and processes enabling near-real time data access for Olema clinical trials
• Ensure quality of clinical data by review for completeness, accuracy, and consistency per study plans
• Support SAE reconciliation between clinical and pharmacovigilance databases and external data reconciliation within the clinical database
• Provide Clinical Data Management subject matter expertise to study team members during all project phases, including audits/inspections
• Lead a team of data management professionals
• Assist in developing and periodically reviewing Data Management SOPs, WIs, and templates; assess metrics and implement improvements

Qualifications

• Required: 15+ years of experience in data management in the clinical trial industry (medical device, pharma, or biotech)
• Required: At least 5 years of experience managing data management professionals
• Required: In-depth understanding of clinical/data management regulations and guidelines (ICH, GCDMP, 21 CFR Part 11, GDPR); functional knowledge of CDISC/SDTM/SDTMIG
• Required: Hands-on experience with EDC systems (e.g., Rave, Veeva)
• Required: Experience managing data management CROs
• Preferred: CCDM certification
• Preferred: Experience across early to late-phase trials; late-phase oncology experience
• Preferred: Knowledge of MedDRA, WHODrug or another controlled thesaurus; PMP certification
• Preferred: Experience with data visualization tools (Spotfire, Tableau, RShiny, Dash)
• Preferred: Programming experience (e.g., SAS, R, Python)

Skills

• Excellent verbal and written communication; ability to advocate positions and engage in constructive debate
• Analytical thinking and problem-solving; adaptability to changing priorities
• Commitment to excellence; strong teamwork and collaboration
• Self-starter with passion for results; fast learner; able to identify challenges and adapt quickly
• Sound judgment, integrity, and professional ethics

Education

• Bachelor‚Äôs degree or higher in science, biology, mathematics, or computer science