Clinical Study Manager job in London, England

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This vacancy has now expired. Please see similar roles below...

An exciting research and development organisation are looking for an energetic Contract Clinical Study Manager to join their London office. If you are passionate about working with others to develop new medicines then this is the life changing role for you.

Job Responsibilities

Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
Leads and optimises the performance of the Local Study Team at country level ensuring compliance with ICH-GCP and local regulations.
Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment and conducting Site Qualification Visits to evaluate suitability and quality risks.
Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.
Ensures all country and site level trial essential documents have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with AZ SOPs.
Plans and coordinates applicable local drug activities (from local purchase or
Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.
Reviews monitoring visit reports (as required and following AZ SOPs) and pro-actively advices the monitor(s) on study related matters.
Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.
Proactively identifies risks and facilitates resolution of complex study problems and issues.
Develops, maintains and reviews risk management plan on country study level: proactively manages sites, stakeholders, local and global vendors and customers to ensure risks are timely identified, mitigated and managed.

Skills and Responsibilities

Minimum of Bachelor's degree in pharmacy or equivalent.
3+ years of experience in the pharmaceutical/biotechnology industry, including experience with IMP requirements.
3+ years demonstrated work experience of successfully managing clinical trials within the pharmaceutical industry, including CRO and contract vendor management.
Ability to plan and execute a clinical trial from an operational perspective.
Experience in protocol development/writing.
Financial management skills as applicable to oversee project expenditures.
Possess advanced computer skills (Microsoft applications, spreadsheets, etc.)
Cross-functional and cross-cultural awareness.
Fluent in written and spoken English.

To Apply

Please click on the Apply button. Kindly include a short note outlining why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Matthew Pike at 02074400639 or upload your CV on our website - www.proclinical.com/send-cv

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.

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