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 the quality and integrity of all clinical data including CRF and edit check specifications, Data Management Plans, data systems validation and UAT, listings generation, as well as ensuring review of clinical data for completeness, accuracy, and compliance.

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 (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
• 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
• Required: Practical knowledge of MedDRA, WHODrug and/or another controlled medical dictionaries
• Required: Knowledge of Project Management Principles
• Required: Deep expertise in Excel and Microsoft Office tools
• Required: Relational database understanding and SQL knowledge
• Preferred: Data Visualization Tools experience
• Required: A minimum of 8+ years of experience in data management in clinical trial industry (pharma or biotech)
• Required: In-depth understanding of clinical and Data Management regulations and guidelines: ICH, GCDMP, 21CFR Part 11, GDPR; functional knowledge of CDISC/SDTM/SDTMIG standards
• Required: Extensive experience managing Data Management CROs
• Required: Deep experience in reviewing clinical data
• Required: Hands-on experience with EDC systems (e.g., Rave), IRT systems, and ePRO systems
• Required: Practical experience building studies using CDISC/CDASH standard
• Required: Experience with data visualization tools (e.g., Spotfire, Tableau, RShiny, Dash)
• Preferred: Experience with management of data flow and curation of biomarker data
• Preferred: Experience with a programming language
• Required: Excellent verbal and written communication and collaboration skills; ability to advocate and engage in constructive debate
• Required: Analytical thinking with problem-solving skills and ability to adapt to changing priorities
• Required: Commitment to excellence; fast learner; strong teamwork and collaboration
• Required: Demonstrated ability to make decisions with incomplete or ambiguous information and high degree of professional judgment
• Required: Impeccable professional ethics, integrity and judgment

Skills

• Data management leadership
• Vendor management
• Data flow design across data sources
• Study planning and protocol development
• Database build and validation specifications
• Data quality review and reconciliation
• Regulatory knowledge (ICH, GCDMP, 21CFR Part 11, GDPR)
• CDISC/CDASH standards
• EDC/IRT/ePRO systems proficiency
• Data visualization tools
• SQL and relational databases

Education

• Bachelor’s degree required; advanced degree preferred

Additional Requirements

• Travel: approximately 5–10% travel