Job Description
Are you a visionary leader ready to shape the future of medical science?
Apex Health Systems is revolutionizing patient care through cutting-edge clinical research. We are looking for a Senior Clinical Research Manager to oversee our critical trial phases and drive scientific excellence in the Bay Area.
As a key member of our leadership team, you will bridge the gap between clinical innovation and regulatory compliance, ensuring that our trials not only meet but exceed industry standards.
Responsibilities
- Design and oversee the execution of complex clinical trial protocols from initiation to completion.
- Ensure strict adherence to Good Clinical Practice (GCP), FDA, and EMA regulatory guidelines.
- Manage budgets, timelines, and resource allocation for multiple concurrent studies.
- Liaise effectively between cross-functional teams, including medical officers, investigators, and regulatory bodies.
- Monitor data integrity, identify trends, and implement corrective action plans to mitigate risk.
- Lead and mentor a team of research coordinators and clinical staff to foster professional growth.
Qualifications
- MD, PharmD, PhD, or Master’s degree in Life Sciences, Public Health, or a related field.
- Minimum of 5 years of experience in clinical research, clinical operations, or a related medical field.
- Deep understanding of ICH-GCP guidelines, IND submissions, and NDA processes.
- Proven track record of leading cross-functional teams and managing high-stakes, high-volume projects.
- Exceptional analytical, problem-solving, and strategic planning skills.