Clinical Operations Manager
Denali Health
Responsibilities Own key site-level metrics: enrollment rates, screen failure rates, protocol deviations, data query resolution times, and sponsor satisfaction scores. Serve as the go-to problem solver when complex site operational challenges arise. Serve as a primary point of contact for sponsors, CROs, and CRAs. Lead SQV calls and follow-ups, triage sponsor communications, negotiate contract terms within authority, and authorize study holds when warranted. Direct trial execution across sites, including workflow mapping, SIV launches, referral engagement, randomization sign-off, and resolution of protocol-level questions. Ensure no study is paused or terminated for site-controllable reasons. Host regular PI touchpoints, attend sponsor and CRA calls, and coach PIs on enrollment performance and expectations. Run the site operating rhythm, such as daily stand-ups, weekly all-staff and PI syncs, and cross-site Lead CRC meetings. Qualifications Deep understanding of clinical research workflows, GCP/ICH guidelines, FDA regulations, and sponsor expectations. Minimum of 2 years of experience managing multiple clinical research sites. Strong ability to figure out complex problems with limited direction. High ownership and bias toward action; comfortable in ambiguity. Willing to travel between Atlanta, GA and Plant City, FL as needed. #J-18808-Ljbffr
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