Location: Remote Australia
Employment Type: Permanent
Reporting To: Clinical Operations head.
Overview
Our client is seeking an experienced Clinical Project Manager to lead the delivery of clinical studies from start-up through to close-out. This role will oversee study planning, execution, timelines, budgets, and cross-functional coordination while serving as the primary point of contact between sponsors, internal teams, and investigative sites.
The successful candidate will work closely with stakeholders across clinical operations, biostatistics, data management, medical writing, safety, medical monitoring, and clinical monitoring to ensure the successful delivery of clinical programs in compliance with regulatory requirements and company procedures.
Key Responsibilities
- Lead the planning, execution, monitoring, and close-out of clinical studies.
- Manage study timelines, scope, budgets, and overall project deliverables.
- Coordinate and oversee cross-functional project teams.
- Act as the primary liaison between sponsors, sites, and internal stakeholders.
- Lead internal and external project meetings.
- Track study progress and provide regular status updates to stakeholders.
- Identify, mitigate, and escalate project risks as required.
- Maintain clinical trial management systems and study documentation.
- Review and contribute to key study documents, including protocols, informed consent forms, and study plans.
- Monitor study budgets and support change control processes where required.
- Ensure compliance with applicable SOPs, ICH-GCP guidelines, and regulatory requirements.
- Bachelor's degree, preferably in a scientific or healthcare-related discipline.
- Minimum 5 years' clinical trial experience within a pharmaceutical, biotechnology, CRO, or healthcare environment.
- At least 2 years' project management experience within clinical research.
- Experience overseeing and supporting CRA activities and study execution.
- Strong understanding of clinical development and the drug development process.
- Sound knowledge of ICH-GCP and relevant regulatory requirements.
- Excellent communication, stakeholder management, and organisational skills.
- Ability to work effectively in a cross-functional environment.
- Strong proficiency with Microsoft Office applications.
- Willingness to travel up to 25% as required.
- Proven clinical project management experience with responsibility for timelines, budgets, and study delivery.
- Strong leadership and stakeholder management capabilities.
- Comfortable operating in a fast-paced, collaborative clinical research environment.
- Proactive, detail-oriented, and able to manage multiple priorities simultaneously.