Contract Clinical Trial Manager (Australia based)

3T Biosciences is solving a major bottleneck in the field of immunotherapy – identifying novel targets that can be used to generate therapies to treat cancer in broad patient populations. We are developing transformative T cell receptor directed bispecific T cell engagers for cancer and other immune-related diseases. Our proprietary experimental and computational technology allows us to identify novel T cell receptor targets as well as clinical toxicities to develop safe and effective therapies.

We’re committed to making a difference for patients. Our ambitious, creative, and collaborative team makes 3T Biosciences the perfect engine to drive therapeutic solutions to reality. We’re looking for enthusiastic and self-motivated team-players to bring their talents to a fast-paced environment.

Contract length: 12 months

Location: Remote within Australia

Reports to: Head of Clinical Operations

Position Summary

The Clinical Trial Manager (CTM) will be responsible for the operational management and vendor oversight of 3T’s clinical trial program in Australia.

This role will act as the primary operational lead for Australian trial execution, with a specific focus on site, vendor and CRO management, including oversight of site-facing activities performed by external partners. The CTM will ensure high-quality delivery of clinical trial activities in compliance with ICH-GCP, applicable Australian regulations, and company SOPs, while working closely with the Head of Clinical Operations and cross-functional stakeholders.

Key Responsibilities

Clinical Trial Operations

  • Support oversight and execution of the Australian Phase 1 oncology trial.
  • Manage operational timelines, deliverables, and milestones related to Australian trial activities.
  • Ensure clinical trial conduct aligns with the protocol, regulatory requirements, and external and internal quality standards (ICH-GCP).
  • Provide operational input into trial planning, risk assessment, and issue resolution.

Vendor & CRO Leadership (Primary Focus)

  • Act as the primary operational point of contact for CROs and clinical vendors supporting Australian sites.
  • Lead vendor oversight activities, including:
    • CRO responsible for site management and monitoring.
    • Central and specialized laboratories.
    • Other specialized vendors as applicable.
  • Review and provide local expertise on vendor plans, deliverables, metrics, and reports.
  • Manage vendor performance, escalation, and issue resolution.
  • Ensure vendors operate in compliance with contracts, SOPs, and regulatory expectations.
  • Review and approve vendor invoices and track vendor budgets related to Australian activities.

Note: While direct day-to-day site communication may be delegated to the CRO, the CTM retains accountability for vendor performance and site outcomes. The CTM will serve as the primary point of escalation for Australian site- and vendor-related issues, ensuring that concerns are addressed through appropriate communication pathways. The CTM will work closely with the Head of Clinical Operations to drive timely resolution and implement corrective actions and lessons learned to strengthen ongoing trial execution.

Site Start-Up & Initiation

  • Support site initiation activities for Australian clinical sites, including:
    • Site initiation visit (SIV) readiness and oversight
    • Coordination with CRO and vendors to ensure site activation timelines are met
  • Oversee site readiness activities, including investigational product logistics, lab setup, and vendor integrations.
  • Support site onboarding and ensure operational consistency across sites.

Regulatory & Ethics Submissions

  • Coordinate preparation, submission, and maintenance of Australian regulatory and ethics documentation (e.g. HREC submissions, CTN/CTX processes, amendments).
  • Manage responses to ethics committees and regulatory authorities in collaboration with Regulatory Affairs and CRO partners.
  • Ensure regulatory and ethics documentation is complete, accurate, and inspection ready.

Safety & Quality Oversight

  • Support safety reporting processes in collaboration with Pharmacovigilance and CRO partners.
  • Ensure appropriate oversight of SAE/SUSAR reporting and safety data flow from sites via vendors.
  • Contribute to inspection and audit readiness activities.
  • Ensure compliance with ICH-GCP, Australian regulations, and internal quality systems.

Cross-Functional & Global Collaboration

  • Work closely with the Head of Clinical Operations, Clinical Development, Regulatory Affairs, Data Management, Biostatistics, and Pharmacovigilance.
  • Support planning and transition activities related to future U.S. trial expansion.
  • Contribute to the development and refinement of operational processes appropriate for a growing biotech organization.

Qualifications & Experience

  • Bachelor’s degree in life sciences or a related discipline (advanced degree preferred).
  • Significant experience in clinical trial operations within the pharmaceutical or biotechnology industry.
  • Demonstrated experience managing oncology clinical trials; Phase 1 and/or first-in-human experience strongly preferred.
  • Strong vendor and CRO oversight experience, including management of central or specialized laboratories.
  • Working knowledge of ICH-GCP, including completion of ICH-GCP E6 (R3) training, Australian clinical trial regulations, and ethics submission processes.
  • Proven ability to operate effectively in a lean, fast-paced biotech environment.
  • Strong organizational, communication, and problem-solving skills.

Key Competencies

  • Vendor leadership and accountability
  • Operational execution in early-phase oncology
  • Regulatory and ethics coordination
  • Risk management and issue escalation
  • Cross-functional collaboration
  • Excellent communication skills

What We Offer

  • A mission-driven environment developing transformative immuno-oncology therapies for patients with high unmet need.
  • Exposure to all aspects of drug development, from discovery to clinical execution.
  • Opportunity for growth as the company advances through clinical development stages.
  • Competitive compensation package, including equity participation.

Please contact [email protected] with your cover letter and resume.

3T Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. 3T is committed to the principle of equal employment opportunity for all employees and does not discriminate on the basis of race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status.