Clinical Trial Project Manager

Medpace is a leading contract research organization serving biotechnology, pharmaceutical, and medical device companies through clinical development services. The Clinical Trial Project Manager will oversee day-to-day clinical trial operations, serve as the primary sponsor contact, manage project plans and risks, and provide cross-functional and vendor oversight.

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
• Responsible for management of study vendor
• Manage site quality, including direct supervision of project Clinical Research Associates and monitoring deliverables

Preferred

• Advanced degree in a health-related field preferred
• Phases 2-3 preferred
• Advanced Health Degree
• Phase 2-3 Experience

Benefits

• Equity grants, which have become very lucrative for our associates.
• Office-based environment with on-site mentors.
• Defined career paths with clear advancement opportunities.
• Industry-renowned onboarding and training programs designed to accelerate professional development.
• Ongoing training and continuous learning opportunities throughout your career.
• Comprehensive health, wellness, retirement, and PTO benefits; benefits may vary based on country.
• Office-based culture with occasional work-from-home flexibility for eligible positions after training; benefits may vary based on country.
• Company-sponsored social events.

Company

• Full-service clinical research organization for biotech, pharma, and medical devices
• Cincinnati, Ohio, USA
• http://www.medpace.com/
• Founded in 1992
• 5001-10000 employees

Qualifications

• Bachelor's degree in a health-related field
• Experience in Phases 1-4
• 3-5 years as a project/clinical trial manager within a CRO
• Strong leadership skills
• Advanced degree in a health-related field preferred
• Phases 2-3 preferred

Required skills

• Clinical Research Organization (CRO) Experience, Clinical Site Quality Management, Clinical Study Vendor Management, Clinical Trial Management, Clinical Trial Phases 1–4, ICH/GCP, Project Timeline Management, Risk Management

Preferred skills

• Advanced degree in a health-related field preferred, Phases 2-3 preferred

Experience

• 3-5 years