Senior Manager, Preclinical Study Management
Core
Oversee externally contracted in vivo and in vitro studies supporting research and early development programs, managing CRO relationships, study design, and financial forecasting.
Role type
Senior Manager, Preclinical Study Management
Builds
Nonclinical outsourced studies for research and early development programs
Domain
Biopharmaceuticals / Preclinical Research
Deliverable
client delivery
Required skills
CRO management, study design, contract negotiation, budget forecasting, GLP compliance, cross-functional collaboration, protocol development, site monitoring
Preferred skills
None stated
Technologies
None stated
Responsibilities
Generate and submit concept sheets to CROs and obtain competitive bids; Work with functional areas to facilitate planning and tracking of nonclinical outsourced studies; Generate SOWs and review/process CRO contracts; Assist in preparation for CRO studies including protocol development and animal orders; Maintain complete and current study files; Conduct CRO site visits for study monitoring; Interface with CMC and Supply Chain to manage test article supplies; Interface with CROs to assure GLP-compliant test article characterization; Assist with investment plan forecasting and invoice processing
Seniority
Senior, hands-on management
