Clinical Trial Manager Clinical Project Manager - Healthcare Resume Se
Clinical Trial Manager Clinical Project Manager - Healthcare Resume Se
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Clinical Trial Manager/Clinical Project Manager Resume

Desired Industry: Healthcare SpiderID: 81514
Desired Job Location: HUMBLE, Texas Date Posted: 10/10/2018
Type of Position: Full-Time Permanent Availability Date:
Desired Wage:
U.S. Work Authorization: Yes
Job Level: Management (Manager, Director) Willing to Travel: Yes, 25-50%
Highest Degree Attained: Masters Willing to Relocate: No

Take charge of managing and coordinating regulatory activities for assigned phase one and two Investigator-Initiated Trials (IITs), ensuring the attainment and completion of designated studies within specific deadlines
Keenly administer sponsor tasks which include Food and Drug Administration (FDA) submissions, such as Investigational New Drug (IND) applications, IND renewals, serious adverse events (SAEs), and protocol amendments
Fulfill various tasks, such as evaluating project goals, planning schedules of project completion, and developing action plans
Support investigators in creating protocol documents and consent forms in adherence to The U.S. Department of Health and Human Services (DHHS) and FDA regulations
Manage the preparation of document submissions for Institutional Review Boards, Data Review Committees, and various regulatory agencies including the FDA
Acquire data from investigators and research coordinators in populating regulatory submissions to the FDA, Data Review committees, Institutional Review Boards in Baylor College of Medicine, Houston Methodist Hospital, Harris Health Systems, and National Marrow Donor Program (NMDP), and Institutional Biosafety Committees in Baylor College of Medicine and Houston Methodist Hospital
Oversee the population of new IND submissions and add protocols to current INDs, patient-specific INDs, internal serious adverse event reports, letters of cross reference, and certificates of analysis (CofAs) while promptly responding to FDA queries
Effectively handle data management maintaining hard and electronic copies of regulatory submissions, data and SAE reports, approval letters, and internal and external communications
Enhance organizational skills as well as the ability to cope within fast-paced working environment and handle strict deadline

Project and Research Management
Regulatory Compliance

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