Del Oshinibosi

Acted as Lead Clinical Data Manager for one or more projects provided support to another Lead Clinical Data Manager for one or more projects. Liaised with clients and colleagues in other functional groups as required. Fulfilled all data management activities/deliverables (study set up ,conduct and database lock phase.) in accordance with the Data Validation Manual (DVM) and/or client documentation. Designate tasks appropriately within the team ensuring all work conducted is completed to the accept

-Reviewed all data management materials (Data Management Plan (DMP), e-CRF specification document, Data Review manuals , CRF completion guidelines) for a given study set up ,conduct and database lock phase. -Assisted in the development of cleaning manuals for clinical studies based on cleaning guidelines provided by clinical science department. -Prepared and led user acceptance testing ( UAT) of trial databases -Escalated EDC issues to EDC Vendor and ensure follow up until resolution.

CDA : - Interacted effectively with the representatives of functional areas (Compound Development Project Leaders, Operational Leaders, ICT Project Leaders, Medical Leaders, Safety Officers, CTLs, Biostatisticians, Data Managers, Medical Writers, Quality Monitoring personnel, Regulatory personnel, etc.) to ensure the eClinical Systems processes and deliveries are fully integrated with the needs of the distinct functional areas. CDM: - Accounted for all the Data Management deliverables at the set u

Providing Clinical expert services and solutions for converting legacy or ongoing clinical trials into a CDISC format. - Analyzed the content and structure of the clinical source data. - Analyzed the clinical trial protocol. - Annotation of Case Report Forms according to the Submission Data Tabulation Model (SDTM) standard - Conversion of study data to SDTM - Generation of metadata (define.xml) based on the Case Report Tabulation Data Definition Specification (CRT-DDS) format -Coordinate the d

Co-ordination of Clinical Data management Activities ( set up ,conduct ,and close out/database lock phase )

Clinical data Management and Managing outsource Studies Activities

Co-ordination of Clinical Data management Activities ( set up ,conduct ,and close out/database lock phase )

Pharmacy