Covance’s work in developing new pharmaceutical solutions has a positive impact on the lives of millions worldwide and there are several great opportunities for you to be a part of this life-saving work.
At our pre-clinical development site in Harrogate, North Yorkshire, we currently have an exciting opportunity to join our team as a Study Director in the Department of Genetic Toxicology.
The job summary is as follows:
- Ensure that a definitive protocol is generated, conforming with the intentions of the study design as agreed with the sponsor.
- Ensure that the protocol is authorised in a timely manner.
- Ensure the study and report are scheduled to meet with Covance's and the Sponsor's needs.
- Ensure that the test and control articles are available, have been suitably characterised and that appropriate technical data are obtained. Also ensure that handling precautions are sufficient to ensure operator safety.
- Ensure that all operating departments involved are conversant with the relevant parts of the protocol. Resolve any problems raised before treatment is started.
- Hold Start Up meetings in line with departmental procedures.
- Ensure that test systems are as specified in the protocol.
- Regularly monitor study phases according to departmental procedures.
- Prepare statements on the significance of any deviations from the study protocol and their impact upon the objectives of the study.
- Review all data to ensure its accuracy and that checking procedures have been observed.
- Be aware at all times of study status; anticipate problem circumstances that may affect its timing, quality or integrity, so as to have them resolved in time by those responsible.
- Ensure study compliance with GLP regulations.
- Ensure adequate and timely response to QA audits.
- Ensure compliance with the Home Office Project Licence requirements.
- Prepare and/or review all portions of interim and final reports. Ensure that the report is concisely but completely written and includes all appropriate information and data.
- Issue protocol amendments in a timely fashion for any planned change to the agreed study protocol where necessary.
- Identify work scope changes and ensure requests are completed in a timely manner.
- Monitor transfer of all study data, specimens and reports to the archives at the conclusion of a study, in accordance with company standard procedures.
- Monitor arrangements for return or safe disposal of all surplus test articles.
- Make decisions regarding necessary changes, document such changes and discuss with the sponsor, gaining agreement where possible.
- Communicate regularly with the sponsor, particularly to identify problem areas which will affect completion date or content of report. Document as appropriate.