Clinical Trials Pharmacy Start‑Up Manager

About the role

The Clinical Trials Pharmacy Start‑Up Manager will lead pharmacy study start‑up activities for a growing portfolio of clinical trials at Royal North Shore Hospital. This senior position works closely with sponsors, investigators and research partners to establish new studies and expand access to innovative therapies.

Key responsibilities

• Lead feasibility assessments, site selection visits, protocol review and operational planning for pharmacy‑related trial start‑up.
• Develop Costing of Services Estimates (COSEs), review study budgets and support financial sustainability of the Clinical Trials Pharmacy service.
• Prepare and oversee study‑specific pharmacy documentation, workflows and implementation processes.
• Collaborate with sponsors, CROs, investigators, research governance teams and other stakeholders throughout the start‑up process.
• Support the Clinical Trials Pharmacy Manager in service delivery and mentor pharmacy staff.

Required profile

• Current registration as a pharmacist with the Pharmacy Board of Australia, no conditions or restrictions.
• Extensive hospital pharmacy experience and demonstrated knowledge of Good Clinical Practice (GCP) and clinical trial governance.
• Proven experience in feasibility assessments, site selection visits, budgeting and COSE preparation.
• Experience leading, mentoring and managing pharmacy staff.
• Strong ability to build effective relationships with sponsors, CROs, investigators and governance staff.

Required skills

• Good Clinical Practice (GCP)
• Clinical trial governance and regulatory frameworks
• Feasibility assessment and site selection visit coordination
• Costing of Services Estimates (COSE) development
• Study‑specific pharmacy documentation preparation