Global Site Contracting and Budgeting Session

ClinBiz Summit 2019 Presentation by Donna Libretti Cooke

In this session, Donna Libretti Cooke, Head of Contracts & Budgets\\Study Start-Up and Conduct Specialists\\Global Clinical Trial Services at Bayer U.S. Pharmaceuticals delivers a presentation on pressing topics within global site contracting and site budgeting. The session took place at the ClinBiz Summit 2019.

Your Instructor

Donna LIbretti Cooke, JD
Donna LIbretti Cooke, JD

Donna Libretti Cooke’s career over the past two decades has spanned the pharmaceutical industry, professional conference development and the legal field as a former practicing attorney. These combined experiences pivoted Donna into a more developed role in clinical operations. She is passionate about enabling streamlined processes to ensure faster study start up times.

As a former Associate Director for PRA Health Sciences, Donna grew and managed a team of over 20 clinical contract specialists at Bayer. This was part of an embedded program at Bayer in Whippany, NJ. For three years, Donna worked very successfully and collaboratively with the Bayer Contracts Manager. She pro-actively managed the clinical operations of this contracts team, from clinical contracts, budget negotiations, to those thorny site payment issues.

Donna’s contributions helped garner her next career step into her current global role as a permanent employee with Bayer, now acting as the centralized Head of Contract and Budgets for Phase II – III clinical trials and Phase I oncology studies. This role is part of a new global organization within Bayer, bringing exciting new challenges, opportunities and increasing levels of responsibility. She’s developing new processes related to global site budgets, a more formal FMV policy and process, as well as sharing best practices with Bayer affiliates related to contracts and budget matters. Additionally, Donna is overseeing a major new initiative for an automated site payment solution at Bayer, with the intention of expanding it globally.

Donna’s former diplomatic experience overseas at the Embassy in Rome, Italy, has additionally helped prepare her for this global role.

Donna’s true passion remains with advocating for patients. While she can do her part in supporting clinical trials, Donna also volunteers as a Patient Educator with the Women’s Cancer Teaching Project (The Connection, Summit, NJ). Donna speaks to medical students and residents about her experience as a triple-negative breast cancer survivor.

Donna’s five-year residency in Rome, Italy spurred her love for travel and historical adventures. She is married with two daughters, residing in New Jersey. But her heart remains in bella Roma!

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