Senior Manager, Clinical Data Management

Role Summary

Senior Manager, 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 and edit check specifications, Data Management Plans, data systems validation and UAT, listings generation, and review of clinical data for completeness, accuracy, and regulatory compliance. Based in San Francisco, CA or Cambridge, MA with approximately 5–10% travel.

Responsibilities

• Day-to-day management of vendors involved in data management to ensure quality of deliverables and that study 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 (e.g., 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
• Assist in the development and periodic review of Data Management specific SOPs, WIs, and templates while assessing metrics and implementing suggested improvements

Qualifications

• Required: Bachelor’s degree or advanced degree in a relevant discipline
• Preferred: CCDM certification
• Practical knowledge of MedDRA, WHODrug and/or another controlled medical dictionary
• Knowledge of Project Management Principles
• Deep expertise in Excel and Microsoft Office tools
• Relational database understanding and SQL knowledge
• Data Visualization Tools experience preferred
• Experience: A minimum of 8+ years in data management in the clinical trial industry (pharma or biotech)
• In-depth understanding of clinical and Data Management regulations and guidelines (ICH, GCDMP, 21CFR Part 11, GDPR) and knowledge of CDISC/SDTM/SDTMIG standards
• Extensive experience managing Data Management CROs
• Deep experience in reviewing clinical data
• Hands-on experience with EDC systems (e.g., Rave), IRT systems, and ePRO systems
• Practical experience building studies using CDISC/CDASH standards
• Experience with data visualization tools (Spotfire, Tableau, RShiny, Dash)
• Experience with data flow management and curation of biomarker data is a plus
• Programming language experience is a plus
• Attributes: Excellent verbal and written communication, analytical thinking, commitment to excellence, collegial, self-starter with a results-focused mindset, fast learner, strong teamwork, decision-making under ambiguity, impeccable ethics

Skills

• Vendor management and project leadership
• Data flow design across multiple data sources
• Data management planning and system validation
• CRF/EDC design and data quality review
• SAE reconciliation and pharmacovigilance coordination
• Data governance, SOPs, and templates development

Education

• Bachelor’s degree or advanced degree in a relevant discipline
• CCDM certification (preferred)