Coordinating and supervising all aspects of a clinical study
Monitors clinical trial sites
Assists Clinical Program Manager in overall study management
Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports
Maintains study timelines
Contributes to development of study budget
Contributes to development of RFPs and participate in selection of CROs/vendors
Manage CROs/vendors
Coordinates review of data listings and preparation of interim/final clinical study reports
May contribute to development of abstracts, presentations, and manuscripts
Ensures effectiveness of site budget/contract process
May be asked to train CROs, vendors, investigators, and study coordinators on study requirements.

BS or BA in a relevant scientific discipline and 6 + years of relevant experience OR RN license (2 or 3 year certificate) and 6 + years of relevant experience
Excellent teamwork, communication, decision-making and organizational skills
Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials
Must be able to generally understand, interpret, and explain protocol requirements to others
Must be able to prioritize multiple tasks
May serve as a resource for others within the company for clinical trials management expertise.

Discretionary annual bonus
Discretionary stock-based long-term incentives (eligibility may vary based on role)
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans

Clinical Trials Manager

Key skills