Cenk Pusatcioglu, Phd Email & Phone Number

North Chicago, Illinois, United States

• Lead the cross-functional study team on clinical studies to manage critical path and milestones.
• Create the study budget and provide oversight of spend against approved budget.
• Supervise study management associates on clinical operations and career development in an inclusive and innovative environment.

North Chicago, Illinois, United States

• Provide oversight of cross-functional teams and vendors for phase 3 trials in the Neuroscience therapeutic area.
• Responsible for providing study updates to key stakeholders and ensuring that database lock activities are completed per plan.
• Participate in business initiatives aimed at improving clinical data review platforms and processes.
• Fluent with clinical systems including EDC, IRT, CTMS and eTMF.

North Chicago, Illinois, United States

• Assigned to a phase 3 trial in the General Medicine Therapeutic Area that covers over 100 sites in the United States, Canada and Puerto Rico.
• Collaborated with cross-functional teams including site monitors, data management, safety and statistics for timely data cleanup, query resolution and database lock.
• Developed training material for study site staff and site monitors.
• Presented at investigator meetings and site monitor teleconferences.

North Chicago, Illinois, United States

• Assigned to the Midwest, Southwest and Pacific Northwest United States regions (40 sites) to ensure timely recruitment, query resolution and triaging of study issues.
• Collaborated with site monitors and the medical director to establish that assigned enrollment procedures are completed per plan.
• Managed the central imaging and lab vendors with weekly meetings, site training/qualification, review of queries and providing feedback for process improvements.
• Generated reports with EDC and IRT to review study metrics and proactively resolve issues.

Deerfield, Illinois, United States

• Coordinated efforts associated with the compilation of site level regulatory document submissions for phase 1-3 clinical trials.
• Prepared, reviewed and managed ethics committee submissions for domestic or international projects, including protocol, informed consent template, financial disclosure, privacy protection and site staff qualification.
• Communicated with central and local/academic institutional review boards (IRBs) and independent ethics committees (IECs) regarding pre-submission strategies or clarification and follow-up of submissions under review.
• Established, maintained and reviewed the trial master file (TMF) to ensure audit readiness.

Chicago, Illinois, United States

• Managed day-to-day operations and clinical staff training for trial implementation.
• Facilitated local institutional review board (IRB) paperwork and start-up operations in coordination with study sponsors and monitors.
• Negotiated contracts with study sponsors to assure successful implementation.
• Led the development of clinical trial protocols, informed consent forms, and privacy protections for study submissions.

Chicago, Illinois, United States

• Managed clinical operations alongside physician and nursing staff in ambulatory surgical centers (ASC) and endoscopy clinics.
• Obtained research participant consent; performed phlebotomy; assessed anthropometrics, and administered medical history questionnaires within clinics.
• Assessed and analyzed dietary intake of research participants using the Block Brief Food Frequency Questionnaire.

Chicago, Illinois, United States

• Captured and managed dietary intake data of research participants with Nutrition Data System for Research (NDSR) software.
• Administered and analyzed Dual-energy X-ray absorptiometry (DXA) scans on research participants.

Bachelor Of Science (B.S.), Food Science And Human Nutrition

Doctor Of Philosophy (Phd), Nutritional Sciences