Jessica Durham
Clinical Trial Manager @Centessa Pharmaceuticals
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WORK HISTORY
Clinical Trial Manager @Centessa Pharmaceuticals
Provide comprehensive project management support across a Global Hemophilia program, including Phase I/IIa clinical trials during maintenance and close-out, as well as a Global Phase IIa Narcolepsy trial in the start-up phase. Oversee CRO and third-party vendors, managing study risks, tracking KPIs, and ensuring adherence to project timelines, deliverables, and study protocol compliance. Lead the management of Decentralized Clinical Trial (DCT) Nursing Vendor, ensuring protocol compliance, accurate study documentation, resolution of quality issues, and timely escalation of site/patient-related challenges. Oversee and manage protocol deviations across the program, collaborating with internal and external teams to ensure accurate and timely reporting, including review of databases, trip reports, and status updates provided by the CRO. Spearhead the creation of patient-facing dosing instructions, providing input on the development of videos and scripts to ensure clarity and accuracy. Review and approve study-related documents, including study plans, site communications, vendor invoices, informed consents, newsletters, risk logs, eTMF, monitoring visit reports, and meeting minutes. Partner with Clinical and Quality Assurance teams to identify clinical sites and investigators for audits, review audit findings, and support the development of corrective and preventive actions. Facilitate clear and effective communication of key decisions and updates to project team members and stakeholders.
EDUCATION
Eldon Career Center
Licensed Practical/Vocational Nurse Training
Columbia College
Bachelor of Science - BS
ABOUT JESSICA DURHAM
Dedicated Clinical Trial Manager with experience in CRO and biotech environments…
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