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Home
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Director Clinical Operations |
| Eligibility : |
Advanced Degree Preferred (MD, PhD or PharmD |
| Location : |
CA/Other |
| Designation : |
Director Clinical Operations |
| 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.
Responsibilities:
Responsible for all aspects of planning and execution of the clinical programs needed to support all Clinical Programs including mentoring and supporting Clinical Program managers and their teams on major programs and having sole strategic and tactical responsibility for “Ventures” (emerging clinical development) programs.
Design, manage and execute all clinical operations activities in support of Venture projects, including development of Investigator Brochure, clinical protocol, paper/electronic CRFs, Informed Consents, Clinical Study Reports and other documents.
Oversee and mentor these tasks by Clinical Program Manager(s) and their teams fro established programs. Input to clinical strategies and selects best option for successful execution of studies; selects vendors/sites/CROs, negotiates budgets and contracts; oversees execution of clinical operations including site supervision and monitoring.
Oversees clinical site and provide assurance of adherence to SOPs, Good Clinical Practice and FDA regulations.
Transition management (or take forward) of Venture projects to full scale clinical development by contributing to timely submission of IND, IMPD or other documents, and contributing to, or leading, development of detailed clinical plans.
Predict need for other clinical staff, and on approval recruit, engage and train such staff.
Requirements:
Advanced Degree Preferred (MD, PhD or PharmD), BS or equivalent may be considered with appropriate experience.
Major course of study in Science or Health-related subject preferred.
Minimum 10 years of experience in clinical research or in a related area. Familiar with a variety of the relevant concepts, practices, and procedures. Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. Leads and directs the work of others. A wide degree of creativity and latitude is expected.
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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 a
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| Salary : |
Not specified |
| Company URL : |
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| Last Date : |
2007-12-26 |
| Address: |
Bob harold |
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