AD/Director – Clinical Trial Management

Job Title: AD/Director – Clinical Trial Management

Job Number: 32925

Location: Remote, 

Job Description

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

Required Skills

• 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; required for home-based
• Management of overall project timeline
• Bid defense experience, preferred
• Strong leadership skills