Director, Clinical Data Management

Role Summary

Director, Clinical Data Management. Responsible for all data processes related to assigned studies, overseeing data collection workflows across all data sources, ensuring the quality and integrity of all clinical data including CRF and 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, to ensure 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 that data collection designs meet study objectives (i.e., System Validation Plans, Data Management Plans, Data Transfer Plans, Data Review Plans, Data Monitoring Plans, and Data Coding Guidelines)
• Develop and review specifications for database build and validation, edit checks, external system integration, or other systems and processes related to data while enabling near-real time data access for Olema clinical trials
• Ensure quality of clinical data by review for completeness, accuracy and consistency in accordance with 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 phases of the project life cycle, including internal and external audits and inspections
• Lead a team of data management professionals
• Assist in the development and periodic review of Data Management specific SOPs, WIs, and templates while assessing metrics and implementing suggested 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: Deep understanding of clinical and data management regulations and guidelines: ICH, GCDMP, 21CFR Part 11, GDPR; functional knowledge of CDISC/SDTM/SDTMIG standards
• Required: Hands-on deep experience working with EDC systems (e.g., Rave, Veeva)
• Required: Experience managing data management CROs
• Required: Experience building studies using CDISC/CDASH standards
• Preferred: CCDM certification; late-phase oncology experience
• Preferred: Programming language experience (e.g., SAS, R, Python)

Skills

• Excellent verbal and written communication; ability to advocate positions and engage in vigorous debate
• Analytical thinking and problem-solving; manage changing priorities and deadlines
• Strong teamwork and collaboration; willingness to share expertise
• Decision-making under incomplete or ambiguous information with professional judgment
• Ethical integrity and sound professional judgment
• Proficiency in Excel and MS Office; relational databases; SQL
• Data manipulation with SAS, R, or Python/Pandas; data visualization tools (Spotfire, Tableau, RShiny, Dash)
• Experience with biomarker data curation and data flow management a plus

Education

• Bachelor’s degree or higher in science, biology, mathematics, or computer science