Clinical Trials Mgr

The Clinical Trials Program Manager is responsible for program facilitation and management support to the Clinical Program Leader and research team. The Program Manager reports directly to the Director, Clinical Research. The Program Manager will manage the clinical trial team to achieve efficient execution of the program plan with the highest possible ethical and scientific integrity.Major Responsibilities Include:
1. Continuous assessment of program needs, including accurate forecasting of program budgets, study supply needs and human resource requirements.
2. Management of CTAs and CRAs in planning, designing, executing and reporting of clinical studies.
3. Coaching, teaching, mentoring and developing the potential of team members.
4. Development of project plans and schedules.
5. Writing of protocols, reports, SOPs and other regulated documents as well as process management tools and other internally utilized documents.
6. Identification of program risk and coordination of risk mitigation efforts and contingency planning.
7. Management of CROs, IRBs, consultants and other outside groups as well as close interaction with multiple internal groups in a matrixed environment.
8. Coordination of the development of papers, abstracts, posters and other presentations of study data.
9. Compliance with and continuing development of Departmental SOPs.
REQUIREMENTS
The position requires a minimum of 6 to 7 years of relevant direct clinical trials experience in the pharmaceutical or medical device industry, with at least three of those years spent directing a clinical research team.Also, excellent interpersonal skills are required, including the ability to perform well in a highly matrixed environment and the ability to serve as an effective leader of a high-function multi-disciplinary team. Finally, excellent oral and written communication skills are an absolute requirement.
The serious candidate will be highly organized, dynamic, confident, creative and well-disciplined.Naturally, a thorough knowledge of and experience with GCPs, ICH and FDA regulatory requirements is requisite, as is great familiarity with Microsoft Project, Microsoft Office, Microsoft Excel and Lotus Notes.