Description:
Job Description: Clinical Trial & Pharmacovigilance Associate (CTA–PV) (CRO Experience)
Location: Melbourne (Remote/Hybrid/On-site options available)
Employment Type: Full time
About the Role
Avion Medical is an Australian-owned, boutique, end-to-end specialist CRO delivering high-quality clinical trials globally. We partner with innovative biotechnology and pharmaceutical sponsors to execute compliant, efficient, and operationally robust clinical development programs.
As our clinical portfolio continues to expand, we are seeking a detail-oriented and proactive Clinical Trial & Pharmacovigilance Associate to support both study operations and safety management across our growing portfolio of trials.
This is an ideal for a candidate with CRO experience who thrives in a fast-paced, evolving environment and is ready to take ownership across both clinical trial coordination and operational safety management.
Key Responsibilities
Clinical Trial Operations:
- Prepare, track, and maintain essential trial documentation including TMF, eTMF, regulatory binders, and study trackers.
- Maintain and update study trackers, ensuring the timely documentation of study milestones.
- Work closely within a multidisciplinary team of Clinical Research professionals
- Assist in study budget and expense management, including oversight of site & vendor payments and budget tracking.
- Generate study status reports, maintain trial metrics, and prepare meeting agendas and minutes.
· Provide administrative support to Clinical Research Associates (CRAs) and Project Managers as needed.
Regulatory and Compliance:
- Ensure documentation is submitted and archived in compliance with ICH-GCP and applicable regulatory requirements.
- Support collection and organization of ethics and regulatory documentation.
- Maintain audit-ready study files.
- Collaborate with study teams to collect and organize essential site documentation, such as investigator agreements and ethics committee approvals.
- Contribute to SOP updates and continuous process improvement initiatives.
Safety & Pharmacovigilance:
- As delegated safety representation on a given trial, r eceive, triage, and process SAEs within required timelines, ensuring accurate entry into the safety database.
- Review safety data for completeness and accuracy, including MedDRA coding verification and case status tracking, and contacting sites where additional information is needed.
- Prepare safety documentation for Medical Monitor review, ensuring appropriate sign-off, and support the preparation and review of SAE narratives.
- Support expedited safety reporting to sponsors and regulatory authorities as required.
· Maintain safety reporting trackers and ensure 100% compliance with reporting timelines.
- Perform reconciliation between EDC and safety databases and resolve discrepancies within defined timelines.
- Educate sites on reporting timelines and escalate non-compliance as required.
- Contribute to DSURs, annual safety reports, and safety narratives.
Qualifications
Education and Experience:
- Bachelor’s degree in Life Sciences, Health Sciences, or a related field.
- 2–4+ years’ experience within a CRO or sponsor environment.
- Demonstrated experience supporting clinical trial operations.
- Experience managing SAE case processing and pharmacovigilance workflows.
- Proven capacity to work across multiple concurrent clinical studies.
· Experience in oncology and/or radiopharmaceutical clinical trials is a plus.
Technical Skills:
- Strong working knowledge of ICH-GCP and applicable safety reporting regulations.
- Proficiency in CTMS, eTMF, EDC, and safety database systems.
- Experience with MedDRA coding review and safety data reconciliation.
- Ability to maintain audit-ready TMF and safety documentation.
- Understanding of regulatory submission processes and reporting timelines.
Soft Skills:
- Excellent interpersonal skills to work effectively with internal and external stakeholders, with adaptability to thrive in a fast-paced, evolving, and rapidly growing organization.
· Ability to prioritize tasks and work under tight timelines in a fast-paced environment.
· Ability to work independently with a high-level of initiative, while effectively taking direction and collaborating as part of a team.
Why Join Us?
- Opportunity to work with a leading Contract Research Organization on cutting-edge clinical trials.
· Competitive compensation and professional development opportunities.
· Opportunity to shape both clinical operations and the PV function within a growing specialist CRO.
· Collaborative culture with hybrid working arrangements and flexibility.