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Job Details

Study Management Associate - Cambridge

Company: CK Clinical
Location: Cambridge
Reference: CL42391
Closing Date: 10 Jul 18
Type: Contract
Salary (£): 60,000 - 80,000

Job Summary:

Russell Oakley is recruiting for a Study Management Associate to join a company in the Pharmaceutical industry at their site based in Cambridge on a...


Russell Oakley is recruiting for a Study Management Associate to join a company in the Pharmaceutical industry at their site based in Cambridge on a contract basis for 12 months initially.

The main purpose of the role will be:

-Coordinating and delivering the administrative Study Delivery (SD) activities within the Study Delivery Team (SDT) as required by each study, to ensure maintenance of relevant systems, and quality and consistency of SD deliverables to time, cost and quality objectives
-Contribute to the development of study documents as appropriate as well as any updates/amendments to those documents
-Lead the preparation of country specific agreements (SMA), confidentiality agreements, clinical trial applications and other applicable country documents.
-Contribute to review of new/amended/unique SOPs and guidance documents
-Ensure the supply of study materials and Investigational product by liaising with Investigational Product Supply or external service providers as appropriate.
-Support the study delivery team in the implementation of audits and regulatory inspections
-Monitor study conduct and progress, proactively identifying and resolving issues which may impact delivery of the study to the necessary quality, timeline or budget objectives with the Associate Director Study Management.
-Interface with Investigators, third party vendors, Marketing Companies and internal staff to support effective delivery of a study and its regulatory documents through finalization of the protocol through to the Clinical Study Report (CSR) and administrative appendices
-Maintain and close the TMF, ensuring continual inspection readiness
-Initiate and maintain production of study documents, ensuring template and version compliance
-Provide input to data management documents (e.g. Case Report Form, Data Validation Specification), and interface with data management representatives and sites to facilitate the delivery of study data
-Prepare presentation material for meetings, newsletters and web-sites

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:

-Degree educated in medical/science discipline or associated clinical research.
-Solid understanding of the drug development process, study management and data management.
-Excellent knowledge of ICH-GCP and basic knowledge of GMP/GDP
-Experience working with vendors and partners
-Relevant, proven administrative experience and organizational skills
-Organised and efficient and with a strong ability for prioritising workload to deadlines

This is an excellent opportunity to join a leading multinational pharmaceutical company.

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group 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 CL42391 in all correspondence.

Apply for this job: Study Management Associate - Cambridge

Contact Information:

Address:  Head Office
9 High Street
Tel:  +44 (0)1438 743047
Fax:  +44 (0) 1438723800
Website:  Visit Our Web Site

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