FSP Sponsor Dedicated - Study Start Up Manager
$74,600–$216,000 year
On-site · Durham, North Carolina, United States
Job Summary
Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources. Essential functions include overseeing site activation and maintenance, developing and maintaining the Management Plan, ensuring regulatory compliance, providing regulatory and technical support for efficient study initiation and maintenance, guiding multi-regional programs, determining regulatory strategy for submissions, contributing regulatory intelligence, ensuring quality standards through QA collaboration, maintaining CTMS and related systems, mentoring colleagues, and advancing relationships with IQVIA customers. The role requires strong negotiation, communication, leadership, and project-management skills, plus deep knowledge of GMP/GCP/ICH and the drug development process. The potential base pay range for this role is $74,600.00 - $216,000.00 annually, with additional compensation possible.
Required Qualifications
- Bachelor's Degree Life sciences or related field
- 7 years’ relevant experience in a scientific or clinical environment including demonstrable experience in an international role.
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