Clinical Research Pharmacy Manager - France, United States
The Pharmacy Manager is responsible for the operational management of the Newark Clinical Pharmacology Unit Pharmacy and ensures the effective operations of the pharmacy at all times including during hours outside of normal working times.
- 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.
- This position has supervisory responsibilities for staff pharmacists, pharmacy assistants, pharmacists and per diem pharmacy technicians.
- Registered Pharmacist/Pharm D with active license in NJ.
- 3-4 years pharmacy practice experience; preferably in a CRO.
- IV Sterile Experience.
- Very good understanding of the Drug Development Process and applicable regulations.
- Exceptional attention to detail.
- Excellent communication skills (interpersonal, written, verbal).
- Excellent knowledge of Microsoft Office Suite including Word and Excel.
- Ability to read, analyze and interpret the most complex documents.
- Ability to work independently, efficiently and accurately with high productivity.
- Experience in conducting complex long-term projects and meeting strict timelines.
- Our company will provide an initial training on our methods, as well as an overview of all services in order to understand the different aspects of the work and to meet the different teams.
- Our company is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, genetics, disability, age, veteran status, or any other characteristic protected by law.