Senior Clinical Program Manager
Remote (USA)
$145,000 - $190,000
Job Description
EPM is partnered with a client at the forefront of revolutionizing the biopharmaceutical industry with cutting-edge precision oncology therapies. They are dedicated to enhancing the lives of their patients, and making these treatments not only more effective, but safer as well. In joining this small team, you will have an unmatched ability to grow vertically within the company, as well as have a large impact on decision making. With strong leadership in place, this is a great opportunity to join a company on the rise in the industry and continue to develop your skills in the clinical research space.
Responsibilities
- Manage all facets of clinical trial operations, including external vendors and site management across geographic regions, to guarantee prompt initiation and timely completion within budget. Ensures strict adherence to SOPs, FDA regulations, and ICH/GCP guidelines. Serves as primary liaison with the CRO overseeing the outsourced clinical trail(s)
- Provide regular reports on study performance and associated resources to the Director, collaborating to enhance processes continually. Conduct training sessions for both internal and external study associates, including CRA's, CTM's, CRO partners, and investigative site staff. Additionally, develop comprehensive training materials for ongoing and future training initiatives
- Effectively manage the study budget and provide approval for vendor invoices
- Engage in cross-functional collaboration to compile necessary documentation for regulatory submissions
- Conduct thorough reviews of lcinical data and metrics, ensuring both quality and the overall health of the clinical trial(s)
- Strategize and oversee the development of study timelines, ensuring the achievement of milestones and facilitating data readouts
Qualifications
- Have a BS/BA in Life Science or a related field with over 6 years of clinical operations experience in the industry
- Ideally 5+ years overseeing Oncology trials - early phase (Phase 1/2) preferred
- Demonstrates effective leadership by leading, mentoring, and fostering the growth of junior staff
- Collaborative team player with strong interpersonal skills, adept at working with various functions such as clinical development, regulatory, and legal for seamless study execution
- Proven track record as a strategic thinker and tactical implemeneter, capable of critical thinking, problem solving, and quick learning in a high-intellect organization
Benefits
- (401(k) with percentage match
- Medical, Dental, Vision
- PTO and Holidays
