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| POSITION DESCRIPTION | AUSTRALIAN BIOTECH INDUSTRY MARCH 2009 |
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Clinical Trials Manager |
| Position Code: | 35 | | Career Level: | 5 |
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Responsible for
Planning, monitoring and managing clinical trials and projects to a high standard of quality and within relevant regulations and guidelines. |
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Reports To
Head of Clinical Development, Research Director. |
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Supervises
Clinical Trials Team Members, external Contract Research Organisation (CRO) resources. |
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Main Activities
Ensuring all activities are conducted in compliance with organisational policies and standard operating procedures as well as regulatory and statutory guidelines.
Liaising with Management to determine project objectives, milestones, performance criteria and strategies.
Identifying relevant resource needs and coordinating their provision in a timely manner. Recommending/implementing strategies to ensure project resource requirements are met.
Managing clinical trial activities in accordance with agreed time-lines and protocols.
Providing technical expertise and advice on therapeutic and clinical research processes.
Liaising with relevant project team members, investigators, overseas collaborators and external partnerships.
Overseeing the review of substantive results from clinical trials as well as ensuring regular reviews are conducted on the scientific and strategic objectives of a project.
Managing the process of transferring highly technical information contained in research papers (either related external publications or internal clinical trial summaries) into useable information for sales & marketing purposes.
Perform feasibility analyses of clinical trials including development of budget proposals.
Undertaking extensive and detailed activities to track and manage project budgets as well as negotiating financial arrangements within agreed limits.
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Key Skills
Proven experience in clinical trials and contract management.
Excellent communication and interpersonal skills.
Proven negotiation, mediation, diplomacy and problem solving skills.
Sound leadership abilities, including conflict resolution, motivational and decision making skills.
A team player, highly organised with an emphasis on procedures/compliance.
Excellent understanding of FDA and European GCP requirements.
Computer literacy - MS Word, Project, Excel Spreadsheet.
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Internal Contacts
Clinical Development Team Members, Project Management Group, Finance, Regulatory Affairs, QA, Business Development, IP, Medical Director. |
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External Contacts
Outsource service and goods providers, research nurses, coordinators, pharmacists, sponsor representatives (potential and existing). |
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Typical Experience
5+ years relevant industry experience coupled with a degree in science or a health care discipline. |
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Other Comments
May be required to travel (regional, interstate, overseas). Requires a high awareness of the industry and its specialist requirements/regulations. |
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