Contract Clinical Study Manager

A leading pharmaceutical client is searching for a Contract Clinical Study Manager to join their team in the UK. The company specialises in various therapy areas including oncology, neurology and gastroenterology, and employs several thousand across the globe.

Job Responsibitlies:

• Sets objectives, delivers results and implements policies and operational targets that have a direct impact on the work unit or operational outcome
• Work may include policy changes or recommendations
• Individual contributor with specialized knowledge
• Has an easily discernible impact on the job area and expected results
• Typically no cost center budget management responsibility
• Executes work procedures in a project context. Consistently exercises judgment and discretion within generally defined procedures
• Technical expert with sufficient expertise and experience to be considered for sensitive or complex assignments
• Called upon to develop solutions utilizing creativity and ingenuity
• Presents concepts, facts, and reports to mid-level internal and external clients to advise of key trends and issues
• Contact with clients and external vendors and troubleshooting routine client inquiries. May represent the organization as a prime contact for technical matters of significant complexity
• Directs the activity of a work team project within the department. May have responsibility for management of highly skilled professional employees
• Work is completed under limited supervision
• Typically reports to an Associate Director or above
• Has primary accountability for operational study level time, cost and quality deliverables
• Manages overall budget for a regional or smaller study (e.g. Ph II)
• Recommends sites to include or exclude from study
• Independently oversees all operational clinical research activities for a study or series of small studies
• Oversees execution of studies according to ICH / GCP guidelines
• Contributes to inspection preparations
• May undertake co-monitoring activities
• Assesses risks and proposes creative solutions or options
• Comprehensively assesses options to address study issues
• Contributes to the development and/ or review of high level study related documents (e.g., PCS, Protocol, CRF etc.)
• Oversees the development of study manuals and monitoring manuals
• Serves as first point of contact for Eisai to CROs and/ or study sites for regional or smaller study (e.g., Ph II)
• Evaluates vendor proposals against Eisai's terms and critical needs and partners with internal functions to define scope of work
• Monitors and assesses vendor performance against contractual operational deliverables
• Monitors progress of sites/ CROs/ vendors against requirements and leads discussion of current status and resolution of issues

To Apply:

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 Matthew Pike on +44 207 4400 639 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.