Global Study Manager

2 days ago


London, Greater London, United Kingdom Medpace Full time

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 Role

We 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
  1. 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.
  2. Serve as primary Sponsor contact for operational project-specific issues and study deliverables.
  3. Maintain in-depth knowledge of protocol, therapeutic area, and indication.
  4. Provide cross-functional oversight of internal project team members and deliverables, which includes ensuring all necessary project-specific training is provided.
  5. Review and provide input for study protocol, edit check specifications, data analysis plan, and final study report, when applicable.
  6. Develop operational project plans.
  7. Manage risk assessment and execution.
  8. Responsible for management of study vendor.
  9. Manage site quality, including direct supervision of project Clinical Research Associates and monitoring deliverables.
Qualifications
  • 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.
Benefits
  • 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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