Lead Pharmacist - Ref. TGB12/048/0226 at Stellenbosch University

Duties/Pligte
Study Set-Up and Planning

• Contributing to protocol development [especially Investigational Medicinal Product (IMP) handling, blinding, dosing schedules] if indicated, and protocol amendments.
• Participating in site selection and feasibility assessments.
• Reviewing and training on the protocol to assess IMP handling, dosing, storage, and destruction.
• Reviewing and training on pharmacy manuals, Investigator's Brochure, package inserts and additional sponsor pharmacist requirements.
• Developing pharmacy-specific SOPs for studies.
• Ensuring pharmacy readiness before site initiation
• Investigational Medicinal Product and Ancillary Medication (if applicable) Management
• Overseeing and/managing the ordering, receipt, storage, labelling, and accountability of IMPs.
• Ensuring that storage conditions meet protocol and regulatory requirements (e.g. cold chain management, quarantine).
• Maintaining temperature monitoring and excursion management.
• Managing/ensuring accurate IMP preparation, compounding, reconstitution, and dispensing as per the protocol, pharmacy manual and sponsor guidelines.
• Ensuring blinding and randomisation integrity.
• Managing returns, destruction and reconciliation of IMPs.
• Ensuring adequate levels of IMP and ancillary medication to ensure uninterrupted participant enrolment.
• Ensuring adequate stock levels of consumables.
• Regulatory and GCP Compliance

Ensuring compliance with:

• Good Clinical Practice (including SA-GCP);
• Local and international regulations (FDA, EMA, MHRA, etc.);
• Local and international training requirements, i.e. GCP, HSP.
• Maintaining accurate and complete pharmacy documentation.
• Ensuring controlled drug compliance where applicable.
• Preparing for and participating in monitoring visits, audits and inspections.
• Ensuring the pharmacy is inspection/audit ready at all times

Patient Safety and Clinical Oversight

• Reviewing dosing appropriateness and IMP safety.
• Advising on possile drug-drug interactions and contraindications.
• Supporting investigators in managing adverse events and serious adverse events.
• Overseeing participant IMP compliance/adherence.
• Ensuring the correct implementation of dose modifications and protocol amendments.
• Providing clinical pharmacy services to study participants, including patient advice and adherence counselling and medicine reviews.
• Assisting the public sector pharmacists with pharmacy duties, and public patient and staff support.

Team Leadership and Training

• Leading and supervising clinical trial pharmacy staff.
• Training pharmacists, assistants, and study teams on:

Protocol-specific IMP handling;

• Blinding procedures;
• Emergency unblinding processes.
• Acting as the primary pharmacy contact for sponsors, CROs, CRA's and the clinical study team.
• Documentation and Data Integrity
• Developing relevant pharmacy logs and documents.

Maintaining:

• IMP and ancillary medication accountability logs;
• Dispensing records;
• Temperature logs;
• Deviation reports;
• Calibration and service certificates.
• Ensuring that pharmacy data supports source data verification.
• Contributing to CAPA (Corrective and Preventive Action) if issues arise.

Communication and Collaboration

• Ensuring that pharmacy and IMP accountability information is ready for monitoring visits.
• Attending all monitoring visits.
• Communicating/meeting with sponsor pharmacy team/representatives.
• Attending to all monitoring findings during monitoring visits.

Liaising with:

• Principaland Sub-Investigators;
• Study coordinators and other study staff;
• Sponsors/CROs/CRAs.
• Participating in trial management meetings.
• Study Close-Out
• Reconciling all IMPs.
• Arranging drug return/destruction.
• Archiving pharmacy documentation per regulatory/sponsor requirements.
• Supporting close-out visits and final audits.

Job Requirements/Pos Vereistes

• Bachelor's degree in Pharmacy (BPharm).
• Registration with the Pharmacy Council (current).
• Practicing licence (current).
• Valid Good Clinical Practice certification.
• At least two years' experience in a hospital or clinical pharmacy setting.
• At least three years' experience as a clinical trial pharmacist.
• Good communication and interpersonal skills.
• The ability to work independently and as part of a multidisciplinary team.
• Sensitivity towards cultural differences.
• Sound understanding of confidential and ethical issues surrounding HIV and TB infection.
• Leadership and mentoring skills.
• Detailed understanding of GCP and regulatory frameworks.
• Clear communication and problem-solving skills.
• Strong clinical trial pharmacology knowledge.
• The ability to work under pressure in a diverse team.
• The ability to maintain strict confidentiality of patients' health issues.
• The ability to maintain sound interpersonal relations.
• The ability to communicate effectively.
• Well-developed administrative and computer skills.
• The ability to prioritise.
• Excellent attention to detail.
• Commitment to patient care and safety.
• Leadership and mentoring skills.
• Good organisational and time-management skills.
• Knowledge of hospital pharmacy systems and procedures.

Closing Date: 10-Mar-2026