[Hiring] Clinical Trials Program Manager @PopVax

Role Description

PopVax is looking for an experienced clinical trial coordinator based in Australia to rapidly scale up our trial capacity and lead our operations in Australia. You will work directly with our clinical sites, coordinating them via visits, calls, and using AI-enabled clinical trial operations software.

As the second hire on our clinical trial team, you will be fully integrated into our clinical development process from the beginning of each new program.

As our first hire in Australia, you will be PopVax's full-time eyes, ears and hands for clinical operations in Australia, and the first call for our clinical site, our reviewing ethics committee, others, as well as the rest of our team. You will be responsible for ensuring that PopVax stays fully compliant with Australian laws and rules, including clinical trial rules, import and export regulations, and tax law, and will work with all stakeholders and contractors to ensure they (and we) rigorously follow Good Clinical Practice at all times.

Tasks

• Serve as PopVax's on-the-ground point of contact for the clinical site, leading or attending site initiation visits, monitoring visits and close-out visits.
• Coordinate aspects of investigational product shipping and handling, including pharmacy manual compliance.
• Help resolve day-to-day queries to and from the site staff and Principal Investigators.
• Own the trial master file (TMF/eTMF) and track all essential documents, keeping them inspection-ready at all times.
• Manage electronic data capture set-up, user access, data queries and data cleaning, with appropriate software and support from PopVax’s India team.
• Act as the named site coordinator for contact required under the protocol, and coordinate additional time zone coverage with our team across India and the UK when needed.
• Contribute to and review HREC applications, and help respond to HREC comments as they arise.
• Prepare annual progress reports and site-specific assessment (SSA) for each participating site.
• Prepare and submit Clinical Trial Notifications (CTNs) for each new trial, and keep the associated CTN records current.
• Register and maintain each future trial's entry on the Australian New Zealand Clinical Trials Registry (ANZCTR) and other registries, including recruitment status and results reporting.
• Working with our medical monitors, follow-up on SAE/SUSAR within required timeframes, send this reporting to the HREC and TGA as necessary, and prepare annual safety summaries.
• Maintain contemporaneous records of our trial expenses and other R&D spend in the form our accountants, tax advisors, and the Australian government require.
• Own the day-to-day relationship with key software and service vendors, including the chosen trial operations platform, data platforms, and clinical CROs, and local bioanalytical labs.

Qualifications

• Based in Australia with existing work authorization.
• 3+ years' experience in clinical trial coordination, monitoring or site management (as a CRA, clinical research coordinator, or site-side trial coordinator), ideally including CRO or sponsor-side experience on Phase I clinical trials in Australia.
• Deep knowledge of the Australian clinical trial regulatory environment: the TGA's CTN and CTX schemes, the ANZCTR, the National Statement on Ethical Conduct in Human Research, the HREC process, safety data reporting, import handling for investigational products.
• A background in the life sciences, medicine, nursing, biomedical or health science, or a related discipline.
• Comfortable being the sole on-ground presence in Australia for a small biotech, with close integration with teams in India and the UK.
• High agency around and ownership of project goals, meticulous documentation habits, and a willingness to take charge of time-sensitive questions related to participant safety.

How to Apply

Please send a cover letter and CV to [email protected]