COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. We are recruiting for our Early Development Unit in Harrogate and are currently seeking to hire a Study Manager (I) role to help support the Immunology & Immunotoxicology team. This is a full time and permanent contract.
The Study Manager ensures that studies are carried to required standards and reviews and approves study data as well as constitutes a single point of study control. He/she has overall responsibility for the scientific, technical and regulatory conduct of studies allocated to them as well as for the interpretation, documentation and reporting of results. Close and regular liaison with the client is of primary importance.
Duties and Responsibilities:
- Ensures that the study is performed in accordance with the study protocol and the Covance standard operating procedures.
- Ensures that the study is performed to the required scientific and regulatory standards.
- Possesses in-depth and up to date knowledge of UK/OECD GXP regulations as applicable, SD roles and responsibilities, organisation of multi-site studies.
- Holds start-up and ongoing study meetings.
- Is aware all times of study status and anticipate problems that may affect timing, quality etc taking appropriate action to resolve such problems.
- Ensures that all study communication is documented and maintained and carried out to meet client requirements.
- 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.
- Is responsible for on time delivery targets (protocols, results, reports.)
- Ensures all studies are costed and quoted appropriately.
- Evaluates existing departmental procedures and systems and participates in process improvements.
- Develops teamwork with study team, business development, QA and other departments.
- Supports and encourages the development of team members.