Clinical Trial Manager
Our client is an innovative company who are driven to transform patients' lives through the development and delivery of pioneering new medicines in Cancer, Infection and Autoimmune disease.
This is a fantastic opportunity for an experienced Clinical Operations professional to oversee management of clinical trial sites from study start-up through to site closure.
Clinical Trial Manager Key Responsibilities:
- Plan, implement and manage clinical trials/assets in compliance with industry regulations, ICH-GCP and applicable company controlled documents
- Oversee management of Clinical Research Organisations and clinical trial sites
- Track site visits and trip report metrics; data quality concerns and site-level trending of protocol deviations
- Conduct oversight site visits to evaluate site and CRA performance and ensure adherence to study protocol, operation plans, ICH-CP and regulatory requirements
- Facilitate Initiation visits to confirm site training of therapeutic indication(s) and associated study procedures
The ideal candidate will have/be:
- Educated to a degree level in a biological, pharmacy or other health-related discipline
- Substantial relevant clinical operational experience in a pharma/biotech company and/or Clinical Research Organisation
- Good understanding of current GCP, ICH, GDP and relevant CFRs, preferably with a familiarity of MHRA/EMA/CHMP regulations and guidelines and other international regulatory requirements
- Experience with start-up and initiation of clinical trial sites
- Ability to communicate and coordinate activities with internal team, clinical sites and vendors
Apply now or please contact Jacqueline Watson for more information
Star OUTiCO is a full service resourcing and outsourcing company which resources at all levels for pharmaceutical, medical devices and technology, clinical research and healthcare communications companies in the UK and Ireland on a headcount and outsourced basis. If you haven't heard from us within 7 working days of submitting your application, please assume that you haven't been successful on this occasion. We wish you the best of luck with your job search.