Date: 10-May-2011
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Clinical Trial Manager
1. Implementing clinical project/study plans in accordance with corporate and regulatory objectives
2. Representing Clinical Operations in program-level meetings regarding a particular trial or trials
3. Developing key study documents in conjunction with other functional area leads assigned to a project (e.g. protocols, project plans and timelines, statistical analysis plans, final study reports, etc.)
4. Identifying and evaluating potential investigators and other service vendors to perform clinical study work
5. Negotiating and securing study budgets and contracts with investigators, CROs, and other vendors. Facilitating and tracking payments to investigators and other service vendors, ensuring compliance with overall study budget.
6. Managing interactions with investigators, CROs, CRAs and other vendors to ensure service meets corporate, regulatory and clinical development objectives
7. Ensuring the quality of monitoring services provided by external vendors
8. Identifying and resolving issues that jeopardize timely clinical study completion
9. Organizing clinical project/study status information to allow for effective reporting to management
10. Coordinating routine client communications in accordance with contract specifications
Required Experience
1. Candidates with a BA or RN with appropriate experience will also be considered.
2. To qualify for the role of Clinical Trial Manager, a minimum of five years experience in the pharmaceutical or biotechnology industry is required.
3. To qualify for the role of Senior Clinical Trial Manager, a minimum of eight years experience in the pharmaceutical or biotechnology industry is required.
4. Candidates must also have demonstrated a history of assuming the lead supervisory role for clinical projects.
5. An advanced degree (Master’s or above) is desirable.
6. Prior experience observing and training Clinical Operations staff is desirable
7. Familiarity with formal concepts of project management and planning is a definite plus.
8. Experience with enrolling difficult populations is helpful.
9. Experience in pediatric clinical trials is desirable.
10. Knowledge of EU Regulations and prior EU Clinical Trial experience is highly
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Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/
