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Job: Clinical Study Manager (Global Trials) – Direct Hire – RTP, NC Pharma, Frankel Staffing Partners, Research Triangle Park, NC
Clinical Study Manager (Global Trials) – Direct Hire – RTP, NC Pharma
Research Triangle Park, NC 27709 United States
Our client, a growing RTP-based pharmaceutical company with multiple products in development, is actively recruiting for a highly capable Clinical Study Manager to join its R&D team. This Study Manager will be responsible for managing global studies for drug programs from early development to regulatory approval.
This company is building, and is in clinical trials (some government-sponsored) with numerous products in various stages of development. This CSM will focus on Phase I-III studies and will oversee all aspects of study design, from analysis and reporting, document creation, vendor selection and oversight, to site monitoring and study budget development and tracking. We seek a versatile Study Manager whose clinical research knowledge is complemented by practiced and proven Project Management capabilities. A lot is happening and we seek a candidate who thrives in a “hub” role.
• Lead integrated clinical study team meetings to ensure high scientific, ethical and regulatory standards, and expeditious registration submissions worldwide
• Construct or review clinical development plans and documents (e.g. protocols, Informed Consent Forms, CRFs, Monitoring Plan, etc. ) and coordinate translations as needed
• Oversee study related site management and monitoring activities
• Responsible for maintaining timelines for key deliverables, to include protocols, case report forms, statistical analysis plans, data management plans, monitoring reports and clinical study reports
• Selection and oversite of study vendors
• Provide proactive solutions to study-related issues
• Establish and maintain effective communication and collaboration amongst all stakeholders.
Ideal candidate will offer a related degree (BS expected) and 5+ years of clinical study management experience including site, CRO and CRA oversight. Phase I-III experience is required, as well as Global program oversight.
In addition, we seek a very sharp, knowledgeable and take-charge professional who will work exceedingly well in a dynamic and collaborative setting; One who can adapt to changing needs and modify personal style to meet each study’s unique needs; One who can gain the respect and cooperation of all stakeholders in order to achieve shared success.
This is an exciting time at an exciting company. We seek a candidate who will contribute and thrive.
Frankel Staffing Partners proudly recruits on behalf of premier employers in the Triangle (and beyond). We specialize in Office Support, Life Science and other Professional Services positions. To view our current openings, please visit our website at www.frankelstaffing.com.
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