This is a brilliant opportunity for an Associate Clinical Operations Manager to join a renowned biopharmaceutical company who have approximately 25000 employees placed in over 170 countries. This particular role will be based in UK. This diverse company who specialise in research and development focus on producing strong clinical performances, assessable patient benefits and economic value.
- Monitors activities conducted by clinical investigative sites as they relate to clinical studies to ensure successful execution of the protocol. This position functions in an off-site and affiliate based capacity.
- The Associate Clinical Operations Manager (ACOM) conducts clinical site monitoring visits across a maximum of 5 protocols and multiple therapeutic areas, ensuring studies are conducted according to all applicable regulations and business processes. Ensures regulatory inspection readiness at assigned clinical sites.
- May be responsible for assignments of greater complexity than the Clinical Research Associate (i.e., greater number of sites, site participating in more complex clinical studies, sites requiring more oversight of operational issues).
- Additionally, the ACOM may train and provide guidance to junior staff.
- Supports the Clinical Operations Manager (COM) and/or Senior Clinical Operations Manager (SrCOM) in the provision of leadership and oversight for activities undertaken by Clinical Operations (CO) Site Management & Monitoring personnel in charge of implementing and monitoring clinical studies conducted within country (ex-US) / region (US) of responsibility.
- In the country/region based, may manage up to 6 SCRAs responsible for site identification, qualification, initiation, interim monitoring and study close-out visits for Phase 1-4 studies.
Education, Skills and Experience:
- Bachelor's Degree required; medical/science/nursing background is preferred.
- Substantial clinical related experience, with proven experience as clinical research monitor.
- Expert knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
- Expert knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
- Experience in on-site monitoring of investigational drug in multi-therapeutic areas desired.
- Proven strong site management and monitoring skills
- Excellent written and verbal communication skills. Written and verbal fluency in English and local language (if not English).
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Theodora Savlovschi-Wicks on +44 203 7520 314 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.