Clinical Trials Operations Director

1 month ago

London, Greater London, United Kingdom Clerkenwell Health Full time

Clerkenwell Health is a leading Contract Research Organisation (CRO) specialising in the delivery of scientifically grounded Clinical Trials. We are seeking an experienced Clinical Trials Operations Director to manage the day-to-day operations of our Clinical Research Facility.

The role entails:

  • Collaborating with Senior Leadership on Business Development to support the Clinical Research Facilities goals
  • Providing leadership and support for CRF operational staff at all levels
  • Overseeing recruitment, development, and management of CRF staff
  • Staying updated on best practices in team management and ensuring staff cohesion and effectiveness
  • Contributing to the development of CRF training programs as needed
  • Managing budgets and financial aspects in collaboration with the Commercial Director and others
  • Advising on financial and contractual project management with the Senior Leadership Team
  • Managing vendor selection and overseeing vendor performance, escalating issues when necessary
  • Ensuring the commercial success of clinical trials by managing participant recruitment and retention
  • Conducting and overseeing clinical trial procedures and regulatory document maintenance
  • Ensuring communication with sponsors, regulators, and vendors for protocol compliance
  • Obtaining informed consent and supporting participants in understanding study requirements
  • Managing adverse event reporting and ensuring all protocol amendments are followed
  • Contributing to trial setup and assessment of regulatory, safety, and logistical requirements
  • Managing CRF resources, including staffing, equipment maintenance, and administrative support

Requirements:

  • Undergraduate degree in a relevant discipline
  • Formal training in Good Clinical Practice (GCP)
  • Extensive relevant experience in operational management, whether in a clinic, research facility, or similar
  • Substantial financial budget experience
  • Previous Line Management experience
  • Ability to be based on site 5 days a week (could have flexibility to 4 days for the right individual)

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