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Study Director in Bioanalytical Services

As a Study Director you will ensure that the studies are carried out to the required standards and approve the study data. You will be the single point of study control and have overall responsibility for the scientific, technical and regulatory conduct of studies allocated to you, as well as for the interpretation, documentation and reporting of results. You will have the responsibility to conduct all work in compliance with applicable regulatory requirements, and specifically those regulations (GxP) specified in the study plans, protocols, or work agreements governing the work in which they are involved. Examples of other responsibilities are:

• To ensure that the study is performed in accordance with the study protocol and the Covance standard operating procedures.
• To ensure that the study is performed to the required scientific and regulatory standards.
• on time delivery targets (protocols, results, reports) Understands PBU process and financial/resource issues. Ensures all studies are costed and quoted.
• To be aware at all times of study status and anticipate problems that may affect timing, quality etc taking appropriate action to resolve such problems
• Ensure that all study communication is documented and maintained and carried out to meet client requirements
• Demonstrates knowledge of customer requirements and plans accordingly (timelines, critical deadlines etc)
• Provides client feedback to team
• Produces study protocols and reports to meet client and regulatory requirements
• Proactively manages client and study changes to meet timelines and ensure all additional costs are captured (workscopes)