Company: CK Clinical
Closing Date: 13 Mar 17
Salary (£): 60,000 - 80,000
Russell Oakley is recruiting for an Associate Clinical Operations Manager to join a company in the pharmaceutical industry at their site based in Maidenhead on...
Russell Oakley is recruiting for an Associate Clinical Operations Manager to join a company in the pharmaceutical industry at their site based in Maidenhead on a permanent basis.
The main purpose of the role will be to:
Monitor activities conducted by clinical investigative sites as they relate to the company's 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.
Further responsibilities will include:
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.
In order to be considered for this role, you will be required to have the following qualifications, 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
Exhibits strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
Excellent written and verbal communication skills. Written and verbal fluency in English and local language (if not English).
Exhibit high degree of flexibility when facing changes in the work environment
Attention to detail and strong interpersonal skills.
Proficiency in the use of personal computers, including experience with word processing, spread sheets, email and web-browser applications.
Working knowledge and high experience with electronic data capture systems and clinical trials management systems.
Strong ability to work independently in a geographic region with minimal supervision.
The ACOM anticipates and proactively solves study-related clinical site issues as they occur and initiates, recommends and communicates corrective action as indicated. The ACOM should use functional expertise and exercise good judgment in seeking appropriate guidance and ensures that follow-up to any and all corrective action is taken at the clinical site and is properly documented.
The ACOM may be assigned as Country Project Lead and serve as a "study Subject Matter Expert (SME)" regarding monitoring/site management tasks in support of Site Management & Monitoring staff assigned to a particular protocols.
25 days holiday, private medical, life assurance, pension (employer contribution) plus others. Further confirmation of this on application.
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL38254 in all correspondence.
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