What are the responsibilities and job description for the Clinical Affairs Lead Coordinator/Manager (Pleasanton, CA) position at CEDENT?
Role Summary
We are seeking a Clinical Affairs Lead Coordinator/Manager to oversee clinical operations, including clinical research and device monitoring. Reporting to senior leadership, this role involves developing clinical strategies, conducting clinical research, orchestrating investigations, and ensuring compliance with global regulatory standards. The ideal candidate will bridge the gap between science and regulation, ensuring the safety and performance of medical devices while collaborating with diverse stakeholders.
Responsibilities
- Lead clinical research functions and oversee all aspects of clinical programs.
- Develop clinical strategies and create detailed evaluation protocols and reports.
- Manage IRB submissions to open, renew, close, and update clinical protocols in compliance with regulations.
- Monitor and evaluate clinical sites, Clinical Research Organizations (CROs), and strategic partners.
- Facilitate patient enrollment and monitor adherence to clinical trial protocols, including informed consent verification.
- Conduct Post-Market Clinical Follow-up (PMCF) activities to assess safety and performance.
- Collaborate with physicians, staff, and cross-functional teams to align clinical strategies with business goals.
- Ensure timely delivery of study materials, maintain records, and report on study progress to leadership.
Requirements
- Bachelor’s or Master’s degree in medicine, biology, pharmacy, chemistry, or a related field; a doctorate is preferred.
- 5–10 years of relevant industry experience, with functional leadership in clinical programs, ideally in medical device development.
- Expertise in global regulatory requirements, including U.S. FDA Regulations, ICH-GCP, and EU MDR standards.
- Strong knowledge of clinical research processes, project management, and stakeholder coordination.
- Excellent analytical, organizational, and communication skills.
- Ability to manage relationships with clinical sites, vendors, and regulatory bodies effectively.
Department: Direct Clients
This is a full time position
