Description
Primary Responsibilities:- Collaborate with cross functional groups to successfully coordinate clinical programs
- Act as primary liaison to CROs and vendors
- Facilitate study start-up with CROs and clinical sites
- Manage study logistics and monitoring activities to ensure that milestones and deliverables are acheived
- Track and report clinical trial information and progress regarding patient recruitment, screening, monitoring, clinical and laboratory data, etc.
- May conduct clinical site, CRO, and/or vendor monitoring visits and co-monitoring visits with CRO staff (pre-study, routine visits, trial master file review visits, vendor qualification or selection visits)
- Monitor the maintenance of the clinical trial master files per SOPs and GCP
- Write or contribute to the development of clinical documents such as, clinical protocols, consent forms, Study Operations Plan, Monitoring Plan, Communication Plan, investigator brochure, clinical study reports, INDs/CTAs, and marketing applications - Assess feasibility for assigned clinical studies and contribute to the investigator/site selection process
- Help ensure clinical trials are conducted in compliance with Federal, State and local regulations, Good Clinical Practice regulations and company SOPs
Requirements:
- Minimum 5 years clinical trial management experience
- 8+ years biopharma industry experience, ideally in clinical research /operations
- BA/BS Degree or Nursing
- Vendor selection and management experience
- Field monitoring experience (from start up through close out)
- Ability to travel up to 25%