- 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
- 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
- Hybrid work-from-home options (dependent upon position and level)
- Competitive PTO packages - starting at 20+ days
- Company-sponsored employee appreciation events
- Employee health and wellness initiatives
- Flexible work schedule
- Competitive compensation and benefits package
- Structured career paths with opportunities for professional growth
- Discounts for local businesses
- Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
- Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
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Associate Director, Clinical Trial Management - Raleigh, United States - Medpace
Description
Job Summary
Medpace is the leading CRO for Biotech companies and is continuing to add established Project Managers to join our Clinical Trial Management Group.
Responsibilities
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries.
Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach.
We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective.
Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.Why Medpace?
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas.
Medpace Perks
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.