[Hiring] Clinical Project Manager @Ingenu CRO Pty

Role Description

Reporting to the Head of Clinical Operations, the Clinical Project Manager is responsible for ensuring allocated studies are conducted to high quality standards, following ICH-GCP and global and local legal regulations, meet contracted timelines, and within allocated budget.

• Attend and run relevant project kick off meetings.
• Develop project plan and documents according to applicable regulations.
• Develop realistic study timelines.
• Assist originator of project with document management such as protocol and participant information forms.
• Coordinate Feasibility planning and selection of sites.
• Manage vendors assigned to the study.
• Manage budget and study specific financial forecasting.
• Track project scope against contract and manage scope changes accordingly.
• Set up sites following SOP’s, protocols, and regulatory guidelines.
• Oversee staffing and project resources.
• Monitor progress of project deliverables against timelines.
• Meet project milestones and deliverables.
• Coordinate internal and external meetings.
• Liaise with internal and external stakeholders to provide ongoing study status updates.

Qualifications

• Bachelor’s degree in related discipline, preferably in life science or equivalent.
• Experience of working within a fast-paced, hyper-growth environment.
• Minimum of 2 years of Clinical Project Management experience.
• Great understanding of international guidelines ICH-GCP as well as relevant local regulations.
• Proven ability to lead and motivate cross functional teams in clinical trials.
• Budget and contracts management experience.
• Strong work ethic and time management skills, with the ability to juggle multiple work streams, projects and deadlines.
• Deep intellectual curiosity, desire and flexibility to learn new topics as needed.
• Excellent analytical and writing skills.
• Advanced communication and collaboration skills.
• Full Australian working rights.