Saheed Alex Adeyeri Email & Phone Number

United States

New York, United States

End-to-end execution and management of clinical trials including study site start-up, training and monitoring; management of IRB interactions, contracts and budgets; proficiency in electronic Trial Master File (eTMF), EDC and CTMS; drug and ancillary supply chain strategy; milestone tracking and vendor management; audit and inspection readiness support.

Bridgewater

• Review the Extended Synopsis/protocol and provides feedback /comments to Project leaders and Clinical teams
• Work in collaboration with other functional team to identify forecasting strategy, IP/Ancillaries/comparators and other requirements for the assigned trials
• Continuously Monitor patient recruitment and adjust the resupply strategy as needed
• Collaboration with internal and external stakeholders to plan the labeling requirements, packaging plan and domestic and international distribution
• Monitor the distribution plan including the IVR activities, making sure that IP are delivered in good condition for patients at all time
• Responsible for the Pre-Audit preparation of assigned trials, making sure that all documentations are correct and available for internal and external auditors

Frankiln Lakes, New Jersey

• Oversaw research and development, IVD, IDE and devices studies for FDA 510(k) submission and IVD CE- application.
• Monitored clinical studies to evaluate new investigational products and performance of BD Vacutainer blood collection tubes for visual observations and selected analytes using various instrument platforms.
• Responsible for planning, budgeting, executing, and monitoring clinical studies of new investigational products, sustaining engineering to support product development and post-market surveillance studies.
• Coordinated and planned receipt, use and return of IUO and study products to and from site(s)
• Monitored sites to ensure protocol, SOP, GCP and regulatory compliance.
• Collected, monitored and reported data generated during clinical conduct in a timely manner through interactions with Clinical Data Manager and/or Statistician.