Clinical Operations Manager

About Denali 

Denali is on a mission to fix what is broken in clinical trials and accelerate therapies from bench to bedside. We are a clinical research site network that focuses on delivering reliable patient enrollment for sponsors faster. At the heart of delivering this mission are the exceptionally talented and dedicated professionals who work at Denali.

If you want to leave a dent on the world, Denali might be the place for you.

The Opportunity 

This is a unique opportunity to take ownership of the successful execution of clinical trials end-to-end in a high-growth environment. It is a large role with significant growth potential as Denali expands its network of sites. If you want to make an impact and grow alongside a mission-oriented organization that is growing rapidly, this might be for you.

Responsibilities 

1. Own key site-level metrics: enrollment rates, screen failure rates, protocol deviations, data query resolution times, and sponsor satisfaction scores.
2. Serve as the go-to problem solver when complex site operational challenges arise.
3. 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.
4. 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.
5. Host regular PI touchpoints, attend sponsor and CRA calls, and coach PIs on enrollment performance and expectations.
6. Run the site operating rhythm, such as daily stand-ups, weekly all-staff and PI syncs, and cross-site Lead CRC meetings.

Who is a good fit?

1. Deep understanding of clinical research workflows, GCP/ICH guidelines, FDA regulations, and sponsor expectations.
2. Minimum of 2 years of experience managing multiple clinical research sites
3. Strong ability to figure out complex problems with limited direction.
4. High ownership and bias toward action; comfortable in ambiguity.
5. Willing to travel between Atlanta, GA and Plant City, FL as needed

How to Apply

Emailyour CV and detail the following to View email address on click.appcast.io:

1. The maximum # of studies you have managed at once
2. The most complex problem you are most proud of solving
3. 2 references