ProClinical is working with an emerging European CRO that is seeking a Study Director to be based at their headquarters in Madrid, on a permanent basis. This Study Director role is the person fully responsible for GLP compliance in a study. SD will be responsible for organizing and coordinating the tasks of a toxicology and safety study in the pharmaceutical and biotechnology industry.
The Study Director will transform the offers issued by the commercial department into studies, reporting progress and results to clients.
- Define the aim of the study plan according to the information presented by business development department and study monitor / sponsor.
- Approve the study plan which is prepared before study initiation by dated signature.
- Report to the study monitor / sponsor on the condition of the study plan.
- Coordinate with the delegated phases the deadlines for the reports.
- Follow the indications of the quality assurance unit.
- Coordinate with the technical director of the study time schedule according to the SOP in place.
- Train and involve to the staff of a study in the aims of the same one and critical points of bearing in mind.
- Ensure test and reference item are properly characterized, identified, used and stored.
- Take a constant follow-up carried out by the personnel involved in the study. Checking the raw data acquisition, test procedure.
- Attend and solve incidents that happen along the study.
- Periodic communications with the study monitor / sponsor and submit interim reports.
- Ensure that computerized systems are suitable for their intended purpose, have been validated, and are fit for use in the study.
Skills and Requirements:
- Three years' experience as SD in pharmaceutical industry.
- Health Sciences Degree required.
- Data analysis, interpretation of analytical results and writing of scientific texts.
- Customer Management
- Team worker
- Report writing toxicological studies under GLP.
- Elaboration and revision of PNTs
- High level of English (spoken and written)
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Alannah Chauhan on +44 203 861 8210 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
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