Director of Clinical Monitoring Oversight

Olema OncologyBoston, Massachusetts

Hybrid Full-time $235K/yr - $250K/yr

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Experience Level

Senior Level Manager

Qualifications

Proven experience in clinical monitoring oversight, preferably in a biotech or pharmaceutical environment. Strong knowledge of GCP regulations and compliance standards. Exceptional leadership skills with a track record of managing teams and fostering high performance. Excellent analytical and problem-solving abilities with a focus on data integrity. Ability to work collaboratively in a fast-paced environment. Strong verbal and written communication skills.

About the job

Our success is propelled by a culture that encourages fearless support, motivation, and constructive challenge among team members. At Olema, we believe that prioritizing our people leads to exceptional outcomes. If you are eager to contribute to an unstoppable mission, we invite you to join us in making a significant impact for our patients, your career, and beyond.

View our latest corporate presentations here.

About the Role: Director of Clinical Monitoring Oversight

As the Director of Clinical Monitoring Oversight, you will report directly to the Senior Director of Clinical Operations and will play a pivotal role in providing strategic and operational leadership for global clinical site monitoring across Olema’s clinical programs. You will ensure that all clinical monitoring activities, whether conducted by internal teams, Functional Service Providers (FSPs), or Clinical Research Organizations (CROs), are executed with utmost quality, consistency, and compliance with Good Clinical Practice (GCP) regulations.

Your responsibilities will include overseeing Olema’s Clinical Monitoring Oversight Leads, regional monitoring teams, and overall site performance. You will also develop and implement monitoring oversight strategies and standards that drive operational excellence, data integrity, and inspection readiness across all clinical trials, focusing on risk-based and data-driven methodologies.

This position is based in either our Boston, MA or San Francisco, CA office and will require approximately 15% travel.

About Olema Oncology

Olema Oncology is at the forefront of developing innovative therapies for breast cancer. Our commitment to excellence in clinical development is matched only by our dedication to creating an inspiring workplace culture where our team can thrive and make a meaningful impact.

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