Associate Director, Clinical Trial Management
United States of America
11 months ago
My client is a leading, top 10 global, full-service Clinical Contract Research Organization (CRO). They provide expert services through Phases I-IV of clinical development across the biotech, pharmaceutical, and medical devices industries.
Through their scientific and methodical approach, my client's objective is to accelerate the global development of safe and efficient medical medicines. They leverage local and global therapeutic and regulatory expertise across all major therapeutic areas, including but not limited to; oncology, hematology, cardiology, metabolic disease, endocrinology, central nervous system, and anti-viral and anti-infective.
Manage and take responsibility for project day-to-day operations in accordance with the contract, ICH/GCP, and any 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.
Oversee internal project team members and deliverables with cross-functional oversight, making sure that all required project-specific training is given.
When appropriate, review the study protocol, change the check specifications, the data analysis plan, and the final study report.
Plan operational projects.
Control risk analysis and implementation
Manage research vendors as necessary
Control site quality and keep an eye on outputs
A bachelor's degree in a health-related discipline is required; an advanced degree is preferred.
Phases I-IV experience, with a preference towards Phases 2-3.
5+ years of experience managing projects or clinical trials for a CRO.
Control of the overall project schedule.
Experience with bid defense is preferred.
Strong leadership skills.