Senior Manager, Clinical Data Management

Senior Manager, Clinical Data Management

Join us at Olema Oncology as we develop better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer.

As the Senior Manager, Clinical Data Management reporting to the Senior Director of Clinical Data Management, you will be 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.

This role is based out of either our San Francisco, CA or Cambridge, MA office and will require approximately 5–10 % travel.

• Manage vendors involved in data management to ensure quality of deliverables and that study timelines are met.
• Design data flow across data sources and vendors.
• Develop and review study plans and protocols to ensure data collection designs meet study objectives.
• Develop and review specifications for database build and validation, edit checks, external system integration, and other processes.
• Review clinical data for completeness, accuracy, and consistency according to 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 during all project phases, including audits and inspections.
• Assist in developing and periodically reviewing data management SOPs, WIs, and templates and implementing improvements.

• Bachelor’s degree or advanced degree in a relevant discipline.
• CCDM certification preferred.
• Practical knowledge of MedDRA, WHODrug, and other controlled medical dictionaries.
• Knowledge of Project Management Principles.
• Deep expertise in Excel and Microsoft Office tools.
• Relational database understanding and SQL knowledge.
• Data visualization tools experience preferred.

• Minimum 8+ years of experience in data management in the clinical trial industry.
• In-depth understanding of clinical and data management regulations and guidelines: ICH, GCDMP, 21
  
  CFR Part 11, GDPR, and functional knowledge of CDISC/SDTM/SDTMIG standards.
• Extensive experience managing Data Management CROs.
• Deep experience in reviewing clinical data.
• Hands‑on experience working with EDC systems, IRT systems, and ePRO systems.
• Practical experience building studies using CDISC/CDASH standard.
• Experience with data visualization tools.
• Experience with management of data flow and curation of biomarker data a plus.
• Experience with a programming language a plus.

• Excellent verbal and written communication and the ability to advocate and engage in vigorous debate to reach the best decision.
• Analytical thinking with problem‑solving skills and ability to adapt to changing priorities and deadlines.
• Commitment to excellence.
• Collegial, self‑starter with a passion for results.
• Fast learner who can identify and change course as required in a fast‑paced organization.
• Strong teamwork and collaboration; gives and welcomes feedback; balances team and individual responsibilities.
• Ability to make decisions in situations with incomplete or ambiguous information where high professional judgment is required.
• Impeccable professional ethics, integrity and judgment.

Base pay range: $180,000–$200,000 annually, plus equity, bonus, and benefits. Total compensation also includes additional benefits. The actual offer may vary based on location, market, job related knowledge, skills and experience.

We provide equal opportunity to all employees and applicants for employment and value diversity. Olema has a culture that celebrates difference.