joseph olaleye

Reviewed clinical protocols, case report forms (CRF) for accuracy and completeness in the Cardiovascular Metabolic & Endocrine (CME), and Oncology therapeutic areas. Managed database activities for six (6) clinical studies.

* Planned, executed, and managed clinical trial activities for CROs and external vendor. Collaborated with internal and external stakeholders to manage study deliverables, timelines, and activities. * Facilitated all components of and participated in face to face investigator, vendor, and local country * meetings. * Managed and directed the setup of study systems IVRS, EDC Central Laboratory and Imaging tools. * Worked closely with vendors to customize these study tools. * Developed key oversight plan to manage activities of CRO. * Prepared and reviewed site contracts and budgets. * Supervised response and questions from regulatory authorities on submission for protocol and amendment. * Ensured electronic Trial Master File (eTMF) is audit and inspection ready. * Prepared and finalized trial documents such as communication, training, recruitment and mitigation, safety, data review, clinical operations plan and closeout plans.

* Facilitated and coordinated work assignments with various functional groups within CMR. Managed key activities for 12 DBL and communicate potential risks to lead Project Managers and Senior Managers. * Reviewed and analyzed metrics for 12 studies in order to identify and manage milestones or risks to project. * Supported Trial Managers in areas of need during DBL by providing customized reports from Inform, ClinPhone, and Impact. * Communicated up-to-date information regarding trial progress to project team members and provided Senior Managers updates on study performance. * Successfully completed DBL activities for 10 Phase 3a studies.

* Managed and implemented global trials including defining the strategic goals and metrics of assigned * studies, within a cross-functional matrix team environment. * Provided direction for overall team goals and deliverables including project timelines, resource allocation, and milestones. Responsible for overall CRO performance (including budget and deliverables). * Led planning, venue selection, organization and logistics for investigator meeting. Coordinated meeting activities with external vendor. * Led the Study Management Team (SMT) planning, reviewing and executing trial activities in collaboration with the R&D company teams. * Contributed to the Clinical Operations templates, work instructions and SOP to ensure best practices. * Participated in product development for the following compounds: Topiramate, Carisbamate and Ortho-EVRA, and anti-NGF monoclonal antibody. * Recipient of Encore Awards in recognition of special achievement and contribution to project team. * Managed and drafted the annual performance review of 2 direct reports.

Responsible for data review of multiple study projects. Successfully achieved database locks for multiple studies. Worked on antidepressant drug for indication in PMDD, anxiety disorder, for Phase IV trials. Supervised data management activities for six (6) clinical studies concurrently and achieved database release within project team timeline.

Associate Director at Dr. Reddy's Laboratories

Dissertation titled “Incidence of Vancomycin Resistant Enterococi in Community Hospital in Westcheter County”, 1997.