What are the responsibilities and job description for the Clinical Trials Manager position at Hunter International, Inc?
Clinical Trials Manager
Whippany, NJ
$60-80/HR
Clinical Trials Manager will be accountable for compliant and high quality management of GMA company-sponsored studies (both non and interventional), Investigator Initiated Research (IIR) and Investigator-Sponsored Collaborative Studies (ISCS) data acquisition projects, and Expanded Access Programs (EAPs).
Clinical Trials Manager Responsibilities:
Clinical Trials Manager Requirements:
Whippany, NJ
$60-80/HR
Clinical Trials Manager will be accountable for compliant and high quality management of GMA company-sponsored studies (both non and interventional), Investigator Initiated Research (IIR) and Investigator-Sponsored Collaborative Studies (ISCS) data acquisition projects, and Expanded Access Programs (EAPs).
Clinical Trials Manager Responsibilities:
- Lead all aspects of clinical studies from planning to execution
- Assigned studies include interventional, non-interventional and data acquisitions within Global Medical Affairs Oncology SBU
- Overall accountable for study management of assigned studies, serve as primary contact for CRO
- Coordinate for fair market value assessment of study budgets; initiate and manage, and support contracting process for vendor and study sites
- IIR and/or ISCS data acquisition projects
- Develop and manage overall project timelines
- Support GMA Medical Leads on overall delivery of the data generated from Oncology Non-Interventional Studies (NIS).
- Manage study drug forecasting
- Assist and/or lead in executing Expanded Access Programs within Oncology MA
Clinical Trials Manager Requirements:
- Bachelor’s degree required; life science preferred
- Masters in Science or Business Administration – preferred
- Extensive (7 years) study management experience involving Phases 2 & 3 studies from planning through regulatory submission; regulatory submission experience a plus
- Understanding of the connection between protocol endpoints, study design, CRF design and data collection; clinical science backyard a plus
- At least 5 years Oncology experience (can be outside of industry)
- Strong written, organizational, and computer (e.g. Excel, power point) skills
Salary : $60 - $0
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