Project Manager – Clinical Research (Gen Med)
Novotech · Sydney
Job description
About the role
The Project Manager will lead the planning and execution of clinical projects for Novotech, acting as the primary liaison between the company and the client. You will oversee all phases from site selection to study close‑out, ensuring compliance with local regulations, ICH GCP, and internal SOPs.
Key responsibilities
- Develop and maintain operational project plans, timelines, and study tracking tools (CTMS, eTMF).
- Manage study budgets, revenue forecasts, and profitability targets.
- Select, evaluate, and manage investigational sites and study vendors.
- Coordinate site logistics, subject recruitment, and monitor site performance.
- Collaborate with Data Management, Pharmacovigilance, and regulatory teams to meet study objectives.
Required profile
- Graduate in clinical or life sciences (or related allied profession).
- Minimum 5 years of experience in clinical research, including project management roles.
- Strong understanding of drug development, CRO operations, and regulatory requirements.
Required skills
- Proficiency with Clinical Trial Management Systems (CTMS).
- Experience managing electronic Trial Master Files (eTMF).
What we offer
- Hybrid working arrangements with full flexibility in working hours.
- Paid parental leave for both parents and flexible leave entitlements.
- Wellness programs and ongoing professional development.
- Inclusive workplace supporting LGBTIQ+, disability, and caring responsibilities.
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Published 2 weeks ago
Expires 1 month from now
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Novotech
Sydney
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