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Clinical Trials Program ManagerClinical Trials Program Manager |
| Eligibility : |
Minimum of Bachelors degree required. |
| Location : |
NJ/Central |
| Designation : |
Clinical Trials Program ManagerClinical Trials Program Manager |
| Details :: |
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Vernascientific |
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Vernascientific is a leader in providing innovative cost-effective services and solutions necessary to achieve and maintain compliance to regulatory and quality requirements while improving product and organizational performance.
The Trials Program Manager will be responsible for providing program facilitation and management support to the Clinical Program Leader and research teams planning and executing a multiple study clinical program relating to a major ophthalmologic medical device program. Studies will be carried out at multiple investigational sites throughout the United States and elsewhere in the world. The Program Manager reports directly to the Director, Clinical Research, with a dotted line relationship to the Business Unit Medical Director, Ophthalmology Systems. The Program Manager will manage the clinical trial teams to achieve the timely and efficient execution of the worldwide program plan with the highest possible ethical and scientific integrity.
Major Responsibilities include:
Coordinating the work of Senior CTAs and indirectly overseeing CRAs.
Coaching, mentoring and developing staff.
Planning and conducting team meetings.
Developing and maintaining the project management process and the tools for managing and tracking clinical studies individually and as an overall program.
Developing program and project plans.
Forecasting and planning program budgets, study supplies, overall resource needs and the timing for provision of those needs, with appropriate communication to stakeholders to ensure meeting program needs.
Identifying and managing program risk and coordinating efforts toward risk mitigation and contingency planning.
Providing critical evaluation of individual study and overall program progress, with development and communication of clear recommendations regarding resolution of potential or emerging issues.
Overseeing the development of documents, processes and policies across the program.
Troubleshooting problems.
Facilitating activities that are common across all studies, such as management of an outside Data Safety Monitoring Board and a Clinical Advisory Board, procurement of needed equipment and supplies.
Assisting in the development of scenarios for timing and location of potential studies intended to meet the world wide registration and commercialization goals of the project.
Managing vendors providing services across studies.
Coordinating development of publications and presentations of study data, and the preparation of training materials for investigators.
Assisting with the preparation of regulatory submissions, both by managing the process of compilation of the materials and by directly contributing written summaries of documents, as needed.
Assisting in team-building activities to enhance program effectiveness.
Documenting content of all contacts with investigators or other site personnel, and assuring that all communications are appropriately circulated and filed.
Working to help define program roles and responsibilities.
Participating in process improvement initiatives.
Compliance with departmental SOPs.
Qualifications :
The position requires a minimum of 8 years of relevant direct clinical trials experience in the pharmaceutical or medical device industry, with at least four of those years spent directing a clinical research team.
Ophthalmology trial experience is highly desirable.
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. Demonstration of project management capabilities is required. Finally, excellent oral and written communication skills are an absolute requirement.
The serious candidate will be highly organized, dynamic, confident, creative and well-disciplined.
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. Minimum of Bachelors degree required.
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Vernascientific is a leader in providing innovative cost-effective services and solutions necessary to achieve and maintain compliance to regulatory and quality requirements while improving product an
|
| Salary : |
Not specified |
| Company URL : |
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| Last Date : |
2007-12-26 |
| Address: |
Bob harold
One washington park
Newark - 07102
NJ/Central |
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