Clinical Development Operations & Programs Associate

Atisama Therapeutics

Melbourne

On-site

AUD 90,000 - 130,000

Full time

14 days+

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Benefits offered by this job

Exposure to senior leadership and day-

Mentoring from Program Director

Competitive remuneration + superann

Job summary

Atisama Therapeutics, a clinical-stage biotechnology company based in Melbourne, seeks an Associate, Clinical Development Operations and Project Management to keep RB042's clinical studies on track and drive the integrated development plan. You will support day-to-day trials with CROs and vendors, maintain timelines, budgets and risk logs while collaborating across functions.

We're looking for 2–5 years in clinical operations, strong Excel/PowerPoint skills, and hands-on TMF/CTMS/EDC experience.

Qualifications

Bachelor's degree in life sciences, pharmacy, nursing or a related field.
2–5 years' experience in the pharmaceutical, biotech or CRO industry, with at least 2 years in clinical operations.
Working knowledge of the drug development process from first-in-human to Phase 2.
Sound understanding of ICH-GCP, and of clinical trial regulations in at least one major region (EU CTR, FDA or TGA/CTN).
Hands-on experience with TMF, CTMS or EDC systems.
Demonstrated project management skills: building timelines, tracking actions and risks, and running meetings.
Strong Excel and PowerPoint skills; familiarity with a scheduling tool (MS Project, Smartsheet or similar).
Clear, organised written and verbal communication, including with external vendors and sites.

Responsibilities

Support study start-up, conduct and close-out for RB042 clinical trials, working day to day with CROs, sites and specialist vendors.
Track site activation, recruitment, data and monitoring milestones against plan; flag slippage early.
Help prepare and review study documents: protocols, informed consent forms, study plans, pharmacy and device manuals, and vendor scopes of work.
Oversee the sponsor Trial Master File (TMF) and support inspection readiness, in line with ICH-GCP.
Coordinate clinical supply and device logistics (drug product and nebulisers) with CMC and vendors.
Support vendor selection, contracting and invoice reconciliation against study budgets.
Help prepare materials for ethics committees, regulatory submissions and investigator meetings.
Maintain the integrated RB42 development plan and timeline across clinical, regulatory, CMC, nonclinical and medical affairs.
Run cross-functional program and study team meetings: agendas, minutes, action and decision logs.
Keep the program risk and issue register current, and track mitigation actions to closure.
Track program and study budgets and accruals with Finance; prepare monthly variance reports.
Prepare program status updates, dashboards and slides for the leadership team, board and investors.
Help build and improve project management tools, templates and SOPs as the company grows.