Clinical Trial Project Manager
Title: Associate Director, Clinical Trial Manager
Perm full time position
Remote - Australia based (ideally Sydney)
About the Company
I’m currently partnering with a cutting-edge, US-based, tech-enabled CRO that’s revolutionizing the way clinical trials are run using AI and advanced technology to drive smarter, faster, and more patient-centric studies. As part of their global expansion, we are growing their teams in Australia, I'm looking for talented professionals to join the mission, ideally looking for candidates with short notice periods or immediately available.
About the Role
The Associate Director, Clinical Trial Manager leads clinical trial operations from study planning through execution and close-out. This role manages sponsor and vendor relationships, develops project plans and budgets, oversees resource allocation, and ensures compliance with GCP and regulatory standards. The position collaborates cross-functionally with clinical, regulatory, finance, quality assurance, legal, and IT teams to deliver high-quality clinical trials, primarily in oncology/hematology.
Responsibilities
- Lead study planning, startup, and operational activities for global clinical trials
- Serve as primary sponsor contact, driving effective communication and escalation
- Develop and maintain detailed project plans, timelines, milestones, and resource management
- Ensure compliance with SOPs, contracts, system requirements, and quality metrics
- Coordinate cross-functional teams (clinical, data management, regulatory, medical writing, finance) as single point of contact and escalation
- Facilitate meetings with internal and external stakeholders to monitor progress and resolve issues
- Oversee clinical site selection, patient recruitment, and site performance monitoring
- Prepare and review study documents such as protocols, informed consent forms, and reports
- Prepare project updates, dashboards, and status reports for leadership and sponsors
- Manage financial aspects including budgeting, milestone payments, and invoicing
- Ensure successful, on-time, on-budget delivery of clinical trials compliant with ICH, GCP, and other regulations
- Contribute to development and improvement of departmental SOPs and templates
Qualifications
- Minimum 5 years project management experience in biotech, pharma, or CRO environment
- B.S. required, advanced degree preferred
- Proven functional leadership or coordination experience in clinical trial management
- Strong knowledge of clinical trial processes and regulatory environment
- Excellent organizational, leadership, and communication skills
- Ability to manage multiple projects and shifting priorities effectively
- Willingness and ability to travel internationally