Clinical Research Manager
Exciting opportunity for a Clinical Research Manager to manage assigned clinical studies and drive processes to meet project milestones and deliverables. This role will maintain compliance with applicable laws, regulations, standards, company standard operating procedures, and corporate policies governing clinical studies. This role requires CRO management and direct study execution responsibilities including study strategy and design, protocol development, CRF design, creation of ICFs, Investigator Brochures, monitoring, implementation of clinical plans, clinical study management, and analysis of clinical data, and clinical reports.
- Manage studies for developed medical devices, working with CROs, principle investigators, medical director, medical support personnel, statisticians, data management, study monitors, CRAs, etc.
- Primary interface and project clinical liaison between customers in areas pertaining to clinical studies.
- Ensuring studies are conducted in compliance with U.S. laws and regulations in CFR Title 21, the international ICH E6 Good Clinical Practices and country specific regulatory requirements.
- Assist Regulatory Affairs in preparing and submitting study request documentation to various regulatory agencies (FDA, CA etc.)
- Oversight of clinical sites, including clinical site contracts, principal investigators contracts, completed financial disclosure forms, site start-up (e.g., completion of regulatory documents and IRB/IEC approvals), subject recruitment, data entry/transcription, timely completion of logs (e.g., Screening/Enrollment and AE logs).?
- Bachelor’s degree or equivalent in Engineering, Health Sciences, or Nursing.
- Minimum of five years of experience managing medical device clinical trials from start to finish, including development and execution of comprehensive project plans, timelines, resource and budget planning, and management.
- Highly developed leadership skills to manage CROs, build and direct clinical project teams to ensure that timeline, cost, and quality metrics are met.
- Thorough understanding of CFR Title 21, International Conference on Harmonization (ICH), Good Clinical Practices (GCP), safety and data management requirements, clinical trials management, regulatory compliance.
- Experience with renal/hemodialysis patients and studies a plus
- Willing to travel up to 40%