Clinical Research Pharmacy Manager H/F Biotrial
- États-Unis
- CDI
- Bac +5
- Service public hospitalier
- Exp. 1 à 7 ans
Les missions du poste
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.
Requirements:
- 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.
- RTT - JNT
- Carte tickets restaurants
- Accord d'intéressement
- Horaires flexibles
- Entreprise bretonne à taille humaine basée à l'international
- Parcours d'intégration pour les nouveaux arrivants
- Accessibilité en transports en commun et parking privés
- Belles opportunités de carrière
Biotrial offers a comprehensive benefits package, including:
- Medical, dental, and vision insurance.
- 401(k) retirement plan with company match.
- Employer-sponsored life insurance and long-term disability coverage.
- Paid company holidays, vacation and sick leave.
- Training and professional development opportunities.
Les étapes de recrutement
Les étapes de recrutement peuvent varier selon l'offre à laquelle vous postulez.
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Premier contact téléphonique par notre service RH.
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Entretien avec vos futurs collègues et le service RH.
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Suivant le poste, vous pourrez réaliser une évaluation de personnalité professionnelle.
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Le poste vous convient ! Nous préparons votre intégration.
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Biotrial en images
Salaire fourni par le recruteur
Publiée le 05/10/2025 - Réf : 3464270/25066229 CRPM/N
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Clinical Research Pharmacy Manager H/F
- États-Unis
- CDI
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