Clinical Trials Pharmacist / Clinical Trials Specialist

Why This Role Matters
The Clinical Trials Pharmacist at Slade Health plays a pivotal role in advancing clinical research by ensuring investigational products (IP) are handled safely, accurately, and in compliance with regulatory standards. This position supports the development of innovative therapies across Phase I-IV clinical trials while maintaining high-quality standards within a TGA-licensed sterile compounding environment. By managing investigational products, documentation, and compliance procedures, the role directly contributes to the success of clinical trials, helping bring new medicines to patients faster and more safely.

Job Description
This is a full-time, manufacturing and compliance-focused role based at Slade Health’s Mt Kuring-gai facility. The Clinical Trials Pharmacist ensures that investigational products are prepared, stored, and managed according to Good Manufacturing Practice (GMP) standards and ICH-GCP guidelines. The role involves the oversight of batch preparation, IP accountability, study documentation, and compliance monitoring, while liaising with sponsors, clinical trial teams, and internal production staff. This role does not involve patient counselling or clinical dispensing but requires meticulous attention to detail, operational oversight, and strong regulatory knowledge. Occasional late finishes (up to 8pm) and minimal on-call responsibilities may be required.

Key Features of the Role: Responsibilities
• Manage investigational product inventory, accountability, and storage records
• Interpret trial protocols, pharmacy manuals, and sponsor instructions to ensure compliant IP preparation
• Support oversight of batch preparation in a sterile compounding facility
• Maintain accurate study documentation aligned with ICH-GCP and GMP requirements
• Liaise effectively with sponsors, CROs, and internal teams to ensure smooth operations
• Identify, document, and manage deviations, incidents, complaints, and CAPAs within the Quality Management System (QMS)
• Participate in process improvement initiatives and risk mitigation strategies
• Maintain inspection readiness for sponsor and regulatory audits
• Contribute to stakeholder relationship management and maintain strong communication with sponsors and internal teams
• Support continuous training and compliance within the sterile compounding environment

Required Qualifications
• Current AHPRA registration for pharmacist applicants
• Strong organisational and documentation skills
• Demonstrated experience in a regulated environment (GMP, TGA, Medsafe, or hospital pharmacy)
• High attention to detail and strong risk awareness
• Ability to manage competing priorities and meet strict deadlines
• Excellent communication, collaboration, and stakeholder engagement skills

Educational Requirements
• Pharmacist Applicants: Bachelor of Pharmacy (B.Pharm), Master of Pharmacy (M.Pharm), or equivalent degree with AHPRA registration
• Non-Pharmacist Applicants: Tertiary qualification in Science, Pharmacy, Biomedical Science, or a related discipline
• Demonstrated training or experience in GMP, clinical trials operations, or regulated quality systems is highly desirable

Experience and Skills
• Experience in sterile compounding, hospital pharmacy, or regulated environments is highly regarded
• Knowledge of clinical trial operations, ICH-GCP, GMP standards, and TGA regulatory requirements
• Ability to interpret and follow clinical trial protocols and sponsor instructions
• Strong organisational, analytical, and problem-solving abilities
• High level of accuracy and meticulous attention to detail
• Ability to work collaboratively with multidisciplinary teams
• Process improvement and compliance monitoring experience
• Effective documentation and record-keeping skills for audits and regulatory inspections

Salary Insights
• Competitive salary based on experience and qualifications
• Pharmacist registration may influence compensation level
• Additional benefits include professional development opportunities, training in GMP and clinical trial standards, and participation in a collaborative, regulated workplace
• Occasional overtime or late shift compensation may apply

Company Overview
Slade Health, a division of ICON Group, is a leading provider of sterile compounding services in Australia and New Zealand. With TGA-accredited facilities in Queensland, Victoria, and New South Wales, Slade Health specialises in the preparation, management, and secure delivery of investigational products for Phase I-IV clinical trials. To date, Slade Health has supported over 700 clinical trials in Australia and 70 in New Zealand, maintaining a strong reputation for quality, compliance, and operational excellence. Slade Health’s focus on GMP standards, continuous improvement, and regulatory compliance makes it a trusted partner for sponsors, CROs, and healthcare organisations.

FAQs
• Q: Does this role involve patient-facing responsibilities?
 A: No, the role is manufacturing and compliance-focused, with no patient counselling or dispensing duties.
• Q: Are late finishes mandatory?
 A: Occasional late finishes (up to 8pm) may be required to support operational needs.
• Q: Can non-pharmacists apply?
 A: Yes, provided they have relevant experience in GMP, clinical trial operations, or regulated quality systems.
• Q: Is sterile compounding experience essential?
 A: Highly desirable for pharmacists; non-pharmacists must demonstrate regulated environment experience.
• Q: Will training be provided?
 A: Yes, comprehensive training in GMP standards, clinical trial processes, and QMS procedures will be provided.

Application Tips
• Tailor your CV to highlight experience in GMP, clinical trials, or regulated environments.
• Pharmacist applicants should emphasise AHPRA registration and sterile compounding or hospital pharmacy experience.
• Non-pharmacists should highlight relevant experience in clinical trials operations, GMP manufacturing, or quality systems compliance.
• Showcase organisational, problem-solving, and documentation skills.
• Demonstrate ability to manage competing priorities and maintain attention to detail.
• Include examples of collaboration with multidisciplinary teams and engagement with external stakeholders.
• Address your experience with ICH-GCP, GMP, and regulatory compliance in your cover letter.