Study manager
Other denominations
Study director; pharmaceutical project manager
Description
Study managers coordinate the different departments of a company. They reach this position following years of experience as an assistant study manager or as a junior professional. Reporting to the manager of the department, this workers are responsible for developing internal research projects at pharmaceutical companies or final consumer-oriented firms, including collaborating with other research centres, coordinating and supervising studies carried out by external centres, planning and overseeing the work of the labourers and analysts and the drawing up of protocols, reports, methods and manufacturing handbooks. This is a highly multidisciplinary role, since the professional may be involved in the initial development stage for a drug, in upscaling it and transferring it to production, performing clinical trials and validating batch processes, as well as taking part in quality assurance audits for external studies or other departments outside their remit. At all times they must adhere strictly to the protocols laid out by the company and the schedule agreed on with external or internal clients, as well as the good laboratory, clinical trial and manufacturing practices standards and procedures by which most of the companies in the sector are governed.
Tasks
- Take responsibility for planning and monitoring drug discovery and development studies.
Draw up protocols in conjunction with the rest of the staff involved in carrying out the studies, ensuring good communication between all of the departments concerned.
Inform staff involved in the studies of the possible risks of taking part.
Undertake the planning of the study, guaranteeing that there are copies of the experiment protocols and work plans, as well as any modifications, available sufficiently in advance.
Supervise the people involved in the studies in which they take part.
Help create a good environment within the organisation and motivate staff.
Draw up the project development protocol for the pharmaceutical development department.
Perform cost analysis for the study.
Coordinate trials contracted in laboratories or alternative organisations, ensuring that the project schedule is met.
Draft technical reports, validation protocols, and statistical and trend analyses. - Inform the area manager and quality assurance manager of any deviations from the protocol, following good practices regulations.
Establish procedures for the method validation and revalidation processes.
Monitor the results from the quality control laboratory and put in place preventive or corrective actions, where necessary. - Ensure compliance with the quality standards detailed in the study protocol.
Ensure that the standardised working procedures, programmes, databases and equipment comply with the good manufacturing practices established by the regulatory agencies.
Keep track of the study in order to ensure compliance with the procedures and protocols, dealing with auditors where required by the quality assurance unit.
Apply the general quality policy, as laid out in the Overall Quality Manual and the Standardised Working Procedures, ensuring that it is adhered to by the staff for which they are responsible. - Control the computer equipment and systems for which they are responsible, verifying compliance with the relevant calibration and maintenance plan.
- Maintain and expand their knowledge, attending specific training courses or seminars relating to the company's fields of operation.
