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Talk to Michael Osenni, the specialist consultant managing this candidate, located in Jersey City

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ttelephone:+1 201-209-2870
30 Montgomery Street, Suite 680, Jersey City, New Jersey, United States of America, NJ 07302

Clinical Trials Manager


Job type
Seeking Competitive Salary + Bonus
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This candidate has 25 years of experience in clinical research, including clinical leadership, clinical operations and project management. She has Phase 1-4 experience, from project inception through regulatory submission, and has managed multiple clinical programs (US and worldwide), often in a very cross-functional environment. As Director, Clinical Operations at Immuncor, she was responsible for establishing the clinical research organization within this blood diagnostics device company.

Earlier, this candidate was a leader of the Clinical Research Operations of the Cambridge division of Wyeth, Inc. This group consisted of 35-50 people and included Assistant and Associate Directors, Medical Writing, Contracts and Outsourcing, Records Management, Clinical Coordinators and Lab Liaisons. She was the project team leader and managed a team of over 20 clinical research associates, including independent CRAs, field and in-house, on multiple clinical programs, at the same time.

She has been actively involved in clinical excellence (guaranteed adherence to Good Clinical Practices and all issues related to compliance, training, risk management and quality for clinical studies), SOP development, EClinical (electronic data capture), safety strategy and review, and operational initiatives. She has also provided oversight, leadership and mentoring for clinical staff, including implementing strategies and management tools to improve operational consistency, quality and financial aspects of clinical programs.

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