Manager, Clinical Operations

Position Purpose
Independently manage multiple Phase 2 and 3 international trials; select and manage CRO and vendor teams; contribute to protocol development, study planning; oversee and track study budgets.

Responsibilities
•CRO and vendor identification and selection process;
•Manage CROs and other study partners (monitoring, data management, labs) for assigned trials;
•Develop and manage vendor and investigator budget and payment process;
•Oversee study activities and execution (investigator recruitment, start-up, enrollment, monitoring, data collection, reporting);
•Prepare and present study progress updates;
•Oversee develop of study documents including protocols, amendments, CRFs, ICFs, and other study documents;
•Organize investigator, expert, and other meetings;
•Contribute to clinical SOP development; and
•Travel an estimated 15% of the time.

Qualifications
•BS in Life Sciences/RN or a related discipline or equivalent with minimum of 5 years industry experience in clinical trial management including monitoring, data management, regulatory, contracts, and technical writing;
•Familiarity with international trials and Phase I-III;
•Solid knowledge of GCPs and ICH guidelines;
•Experience managing CROs;
•Demonstrated skill in study budget development;
•Computer proficiency;
•Excellent written and verbal communication skills;
•Energetic, positive, flexible, team-oriented, and interested in professional growth