Study Director

Marketplace Technical
11 Jan 2018
10 Feb 2018
Contract Type
Full Time

Award winning Pharmaceutical Developer requires a Project Manager / Study Director.

Main purpose of job

To project manage scientific research studies in line with GXP and GMP regulations.


    To perform research and development in line with study plans, testing protocol, timelines, GxP or GMP regulations.To provide support in study/project transition from first principles of pharmaceutical development to GMP supplies in line with GxP regulationsTo adhere to Standard Operating Procedure (SOPs). Contribute to the preparation and review of SOPs and Forms where applicable.Maintain projects in internal project management software To contribute to the writing of study plans/ testing protocols and corresponding reports and updates for Sponsors.Management of project timelines Management and contribution to client minutes associated with project TC’sTo assist in the smooth running of laboratory activities in line with GxP regulationsTo assist in the smooth running of activities in line with GMP regulations where applicableMaintain client relationships and to identify opportunities for additional work or alternative projects with clientsTo report any amendments and deviations from SOPs and study plans/ testing protocols to the Study Director/Principal Analyst as appropriate.To adhere to Health & Safety Policy and COSHH regulations at all times and to ensure the safety of others in any procedures or tasks performed.To collaborate with suppliers upon instruction from the Laboratory Manager and /or Senior Study DirectorTo collaborate with Sponsors/potential Sponsors when required.To review literature in preparation for studies and to regularly update knowledge by reviewing appropriate literature.Present approved work to stakeholders, conferences and to clients.Ensure that all documentation, computer data and records are stored appropriately.Assist Data Processors to ensure the correct spreadsheets and data analysis is performed.To review project workbooks and data as per SOPs.To perform appropriate tasks in line with your job at the request of Senior Management

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