Clinical Research Pharmacy Manager H/F Biotrial

Responsibilities:

- Manage the Pharmacy Operations in accordance with Good Manufacturing Practices and Good Clinical Practices.
- Oversee and participate in the daily operations in the pharmacy: supply, storage, packaging, re-labeling, dispensing, accountability, returning or destruction of OTCs or investigational drugs.
- Draft and/or review the study specific pharmacy procedures/ pharmacy manuals and act as technical advisor to the clinical teams and other departments within Clinical Pharmacology.
- Supervise and prepare the IMPs for dosing in accordance with the Protocol and the legislation in effect.
- Prepare the Trial Master Files of each study in collaboration with the Clinical staff.
- Manage the randomization codes.
- Perform or oversee the extemporaneous reconstitution of IV/SC drugs under laminar flow hood and oral solutions.
- Manage the equipment and medications in the crash carts.
- Give pharmacy feasibility input on new proposals and liaise with Sponsors regarding the pharmacy/dispensing capabilities.
- Assist operations and client managers with Sponsor audits, initiation and monitoring visits, and other interactions as appropriate.
- Train the pharmacy staff (pharmacy assistants, pharmacists and per diem technicians) and ensure they follow internal SOPs and the current Good Manufacturing Practices (GMPs).
- Ensure the pharmacy facilities and processes are compliant with most recent regulations/guidelines and interact with regulatory bodies relevant to the pharmacy department.
- Work in close collaboration with the clinical teams (investigators, nurses, technicians, etc.) and the project management team.
- Track the monitoring of the temperature / hygrometry in the pharmacy areas.
- Monitor the hygiene in the pharmacy (Bio-cleaning, control of microbial contamination of surfaces).
- Ensure that the pharmacy SOPs are accurate and up to date.