Senior Manager, Clinical Data Management

Senior Manager, Clinical Data Management

Join to apply for the Senior Manager, Clinical Data Management role at Olema Oncology
. Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2− metastatic breast cancer. Our follow‑on product candidate, OP-3136, is a potent KAT6 inhibitor with best‑in‑class potential.

We accelerate scientific breakthroughs by supporting, motivating, and challenging one another. At Olema, we put people first so our work becomes second to none. Join us to make a profound impact for our patients, your career and beyond.

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.

• 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

Knowledge

• Bachelor’s degree or advanced degree in a relevant discipline is required
• CCDM certification preferred
• Practical knowledge of MedDRA, WHODrug and/or another 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

Experience

• Minimum of 8 + years of experience in data management in the clinical trial industry (pharma or biotech)
• 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 (e.g., Rave, IRT, ePRO)
• Practical experience building studies using CDISC/CDASH standard
• Experience with data visualization tools (Spotfire, Tableau, RShiny, Dash)
• Experience with management of data flow and curation of biomarker data a plus
• Experience with a programming language a plus

Attributes

• Excellent verbal and written communication skills, coupled with the ability to advocate for a position and engage in vigorous debate to reach the best decision
• Analytical thinking with problem‑solving skills and the ability to adapt to changing priorities and deadlines
• A commitment to…