Global Study Manager
2 days ago
Join Medpace, a leading Contract Research Organization (CRO), and contribute to the acceleration of global medical therapeutics. Our team provides Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries.
About the RoleWe seek an experienced Clinical Trial Manager to manage day-to-day operations of projects, ensuring compliance with ICH/GCP and all applicable laws, rules, and regulations. You will serve as the primary Sponsor contact for operational project-specific issues and study deliverables.
Your expertise in Cardiovascular/Endocrine/Metabolic therapeutic areas is welcome, but not required. You will maintain in-depth knowledge of protocols, therapeutic areas, and indications, and provide cross-functional oversight of internal project team members and deliverables.
Responsibilities- Manage and provide accountability for day-to-day operations of projects, 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.
- Bachelor's degree in a health or life science-related field; Advanced degree in a health or life science-related field preferred;
- Experience in Phases 1-4; Phases 2-3 preferred;
- Minimum of 5 years of Clinical Trial Management experience, CRO experience preferred;
- 5+ years of Project Manager/Clinical Trial Manager experience at a CRO required for a remote-based role;
- Management of overall project timeline;
- Bid defense experience preferred;
- Strong leadership skills.
- A competitive salary of £65,000 - £85,000 per annum.
- Flexible work environment.
- Competitive compensation and benefits package.
- Competitive PTO packages.
- Structured career paths with opportunities for professional growth.
- Company-sponsored employee appreciation events.
- Employee health and wellness initiatives.
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