Project Manager – Clinical Research
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 ensure projects are delivered on time, within budget, and in compliance with ICH GCP, local regulations, 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.
- Oversee site selection, ethics and regulatory submissions, and site logistics.
- Drive subject recruitment, monitor site performance, and coordinate monitoring activities.
- Collaborate with data management, pharmacovigilance, and vendor managers to ensure study objectives are met.
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
- ICH GCP knowledge.
- Experience with Clinical Trial Management Systems (CTMS).
- eTMF management.
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 1 day ago
Expires 1 month from now
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Novotech
Sydney
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