Senior Pharmacist (Chief Study Pharmacist)

Job Description: Senior Pharmacist (Chief Study Pharmacist) – PROPS Trial

Project: PROPS Trial (Efficacy of Probiotic Supplementation in Preterm and Small-for-Gestational-Age Infants)
Duty Station: Central study office/pharmacy, King Faisal Hospital Rwanda Foundation, Kigali, with oversight of investigational product (IP) storage at participating study hospital sites
Reports to: Principal Investigator, with functional reporting to the Study Sponsor/Coordinating Centre on investigational product (IP) matters
Employment Terms: One year (Renewable), for the duration of the PROPS trial at the Rwanda site, renewable subject to performance and funding

Position Overview

The Senior Pharmacist (Chief Study Pharmacist) will have overall responsibility for the receipt, storage, blinding integrity, allocation, distribution, monitoring, accountability, and destruction of the investigational product (IP) and placebo used in the PROPS Trial. The Chief Study Pharmacist will ensure that all investigational product management activities are conducted accurately and in strict compliance with the Investigational Product Management SOP, Product Provision SOP, Good Clinical Practice (GCP), applicable national pharmaceutical regulations, and trial requirements.

The Chief Study Pharmacist will oversee central receipt and storage of investigational product, coordinate IP overlabelling and blinding activities, maintain participant ID master lists, manage site-level IP supply and replenishment, monitor temperature and storage conditions, oversee IP accountability and reconciliation, and coordinate end-of-study destruction. The position will also provide supervision, training, and technical guidance to pharmacy and unblinded support staff involved in trial IP management.

Key Responsibilities

• Ensure investigational product is stored immediately under controlled temperature conditions of 2–8°C upon receipt and maintained under continuous temperature monitoring.
• Coordinate and directly oversee the unblinded team responsible for overlabelling individual IP sticks to obscure manufacturer batch numbers while preserving the integrity of trial blinding and complying with applicable regulatory requirements.
• Ensure that IP Temperature Deviation Logs are completed for any period during which IP boxes are outside the required 2–8°C storage range during overlabelling activities, and ensure that overlabelling records are complete and accurate.

• Maintain the master lists of available participant IDs separately for preterm and term SGA infants and generate and verify daily sub-lists for IP allocation across participating study sites.
• Reconcile participant ID master lists on a daily basis, recycle unused participant IDs where permitted, and ensure unused participant boxes are appropriately reissued to minimise product wastage.
• Review and approve requests from site/hospital pharmacists for IP box shipments, ensuring participating hospital sites maintain an appropriate buffer supply, including at least a two-week supply where required by the study.
• Ensure IP shipments to participating hospital sites are dispatched in appropriate temperature-controlled containers, including cool boxes with icepacks and thermometers, with complete and accurate shipment documentation.
• Ensure the PROPS IP Temperature Monitoring Log, including required AM and PM readings, is completed at every storage location and that temperature excursions are promptly reported to the Site Principal Investigator within the required timeframe.
• Monitor cumulative time that IP sachets are outside the required 2–8°C range and ensure that applicable study thresholds are not exceeded, taking appropriate corrective action where thresholds are approached or breached.
• Serve as the primary point of contact for the Sponsor, Coordinating Centre, external monitors, auditors, and relevant regulatory stakeholders on all investigational product-related matters.
• Maintain inspection- and audit-ready IP accountability records, including receipt, storage, overlabelling, allocation, distribution, temperature monitoring, reconciliation, return, and destruction records.
• Lead end-of-study reconciliation of remaining, unused, and expired investigational product and coordinate destruction in accordance with applicable regulations and Sponsor/Coordinating Centre requirements.
• Coordinate destruction of expired or unused IP with an appropriately licensed incineration facility and ensure all required approvals and documentation are obtained.
• Obtain and retain incineration certificates and ensure the PROPS IP Destruction Log is completed accurately and retained within the study records.
• Supervise, train, and mentor Pharmacist(s) and pharmacy/unblinded support staff on the Investigational Product Management SOP, Product Provision SOP, and other relevant trial procedures.
• Monitor compliance of pharmacy staff with study-specific procedures and ensure that required training and certifications are maintained throughout the trial.
• Maintain and, where necessary, escalate proposed updates to IP-related SOPs, logs, forms, and processes in collaboration with the Principal Investigator and Coordinating Centre.
• Ensure all pharmacy staff complete and maintain current ICH-GCP certification and study-specific training before undertaking trial-related IP activities.
• Identify, document, and escalate IP quality concerns, temperature excursions, stock discrepancies, supply interruptions, and other issues that may affect participant safety, trial integrity, or study compliance.
• Ensure strict confidentiality and protection of information related to participant IDs, investigational products, randomisation, allocation, and trial documentation.
• Support the Principal Investigator and study team with other pharmacy and investigational product management duties required for the successful conduct and closeout of the PROPS Trial.

Qualifications and Experience

Essential

• Minimum of Bachelor of Pharmacy (BPharm) or equivalent professional pharmacy qualification.
• Current registration and valid license to practice as a pharmacist with the Rwanda Pharmacy Council or equivalent national regulatory body.

• Minimum of ten (10) years of post-registration professional experience, including experience in hospital pharmacy, clinical trial pharmacy, investigational product management, pharmaceutical supply-chain management, or related areas.
• Demonstrated experience in pharmacy operations, pharmaceutical inventory management, storage, distribution, and accountability.
• Prior supervisory or team-leadership experience.
• Current ICH-GCP certification, or demonstrated willingness and ability to complete the required certification before undertaking trial activities.
• Working knowledge of Rwanda FDA requirements and applicable national pharmaceutical and regulatory requirements for clinical trials.
• Demonstrated ability to maintain accurate pharmaceutical records, accountability documentation, and temperature-controlled storage records.
• Strong understanding of confidentiality requirements and the importance of maintaining trial blinding and allocation safeguards.

Preferred

• Master's degree in Pharmacy or related pharmaceutical sciences.
• Doctor of Pharmacy (PharmD) qualification.
• Prior experience managing investigational products in a clinical trial.
• Experience with blinded clinical trial products and overlabelling procedures.
• Experience managing temperature-sensitive pharmaceutical products and cold-chain systems.
• Experience coordinating pharmaceutical supply and inventory across multiple hospital sites.
• Experience supporting clinical trial monitoring visits, audits, or regulatory inspections.
• Experience with clinical trial IP management systems, electronic tracking systems, or tablet-based applications.
• Experience working with international research institutions, Sponsors, or clinical trial Coordinating Centres.

Required Technical and Management Skills

• Investigational product management.
• Clinical trial pharmacy operations.
• Good Clinical Practice (GCP).
• Good Pharmacy Practice.

• Pharmaceutical inventory and stock management.
• Cold-chain management and temperature monitoring.
• IP receipt, storage, allocation, distribution, reconciliation, and destruction.
• Blinding and randomisation safeguards.
• Pharmaceutical documentation and accountability systems.
• Temperature deviation and excursion management.
• Multi-site pharmaceutical logistics and supply management.
• Quality assurance and regulatory compliance.
• Audit and inspection readiness.
• Staff supervision, training, and mentoring.
• Risk identification, problem-solving, and corrective action.
• Confidentiality and protection of trial information.
• Electronic data, inventory, and IP tracking systems.
• Microsoft Office and relevant pharmacy or study management systems.
• Report writing and documentation skills.
• Understanding of clinical research and pharmaceutical regulatory systems.

How to Apply:

Interested candidates should apply via this link by October 05, 2026