About iNGENΕ« CRO
iNGENΕ« is the FDA-centric Australian CRO championing disruptive, innovative US and global biotech firms. We are physician-led, providing access to the full spectrum of clinical and nonclinical research services.
Our core mission is to create access to high quality clinical research globally, for early to mid-stage biotechs by removing financial and other unnecessary barriers.
About the role
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.
Responsibilities:
- Your responsibilities will involve end-to-end management of assigned clinical studies, and will include (but may not be limited to) the following duties:
- 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.
Skills & Experience
- 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.