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Responsibilities:

• Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations

• Serve as primary Sponsor contact for operational project-specific issues and study deliverables

• Maintain in depth knowledge of protocol, therapeutic area, and indication

• Provide cross-functional oversight of internal project team members and deliverables, which includes ensuring all necessary project-specific training is provided

• Review and provide input for study protocol, edit check specifications, data analysis plan, and final study report, when applicable

• Develop operational project plans

• Manage risk assessment and execution

• Manage study vendors where applicable

• Manage site quality and monitoring deliverables

Qualifications:

• Bachelor’s degree in a health-related field; Advanced degree in a health-related field preferred

• Experience in Phases 1-4; Phases 2-3 preferred

• 5+ years as a project/clinical trial manager within a CRO

• Management of overall project timeline

• Bid defense experience, preferred

• Strong leadership skills