Oracle Clinical, Medidata Rave, Inform, Veeva


Dynamic Senior Manager with extensive experience at ICON Clinical Research, excelling in strategic planning and talent development. Proven track record of exceeding performance targets while leading cross-functional teams. Expertise in database development and resource allocation, fostering a culture of collaboration and operational excellence. Committed to driving project success and team growth.
Responsible for providing line management leadership to the data management teams across functions.
Ensures team deliverables to expected quality and timelines, provides technical oversight as needed, and mentors/develop Clinical Data Management Team leads, Group leads and other staff.
Recognize, exemplify and adhere to ICONS values with centre around our commitement to people , clients and performance.
Ensure teams achieve productivity and aquality targets, perform bench marking reviews and peform oversight of deliverables.
Identify and organize the training needs a appropriate.
Perform Interim/ Annual performance apprisals of assigned team members and idengity gap and propose development plans.
Recognize, Ememplify and adhere to ICONS values wich centers around commentment to people, clients and performance.
Support and Mentor Clini cal Data Managemtn team leaders and extend technical expertise.
Ensures teams achieve productivity and quyality targets, Perform benchmarking review and peform oversight of deliverables using differnt tools/technicques and maintain report revelent metrics.
Idenfity and organixe the training needs appropriate.
Support Recruitment process.
Perform Interim/Annual performance apprisal of assigned team members and idengity gaps and propose development plans.
Support project management of activities suppoerted in all locations, laise with study teams and escalate issues to local management and global study teams ina timely manner.
Responsible for leading and overseeing setup and maintenance as well as providing technical support related to Clinical Data Management Systems.
To Drive activities related to building study databases and apply competent knwledge in the programming fo CRF design, database vuilding, edit checks, reports, custom programming.
Review datavase specifications crated by study teams.
Creates/Program edit checks, special actions/functions, custom programs and derivations.
Plans and scheduled edit check test script wrting, edit check programming and edit check validation.
Database Build, maintenance and reporting activities ensuring timely delivery of each task within the overall study timelines.
Develop and maintain project specific databases for the entry.
Develop and validate edit check rules and other programs as required.
Load data into the clinical database when the data is received eectronically.
Format and transfer databases for statistical analaysis according to study/client requirements.
Leads the Clinical Data Managemetn process for individula clinical trials.
Coordination and development of clinical databases including process of case report forms and electronic data in accordance with ICH/GDP guidelines.
Assist in planning, constucting, testing, data validation programming, receipt of external data transfers, prepare data transfers according to client specifactions and maintenance of clinical database management systems in Oracle Clinical, Clintiral and Medrio.
Leads the clinical data management process for individual clinical trials.
Coordination and development of clinical databases including process of case report forms and electronic data in accordance with GCP, ICH Guidelines.
Assist in planning, construction , testing , data bvalidation programming, receipt of external data transfers, prepare data tranfers according to client specifications and maintenacne of clinical database managemetn systems in oracle clinical, Clintirl and Medrio.
Management of Clinical Data Management Projects including CRF design, Database development, Processing of Case report forms and electronic data, Medical coding, Data review and databvase close/Lock.
Responsible for leading Data Management activities for a project including timelines, budget and quality management.
Career started with 6 months intensive end to end training on Clinical data management at Paragaon Biomedical , UK Office.
Leads the clinical Data Managemetn process for individula trials.
Coordination and developmen of clinical databases including process of case report forms and electronic data.
Coordina tof a group of staff working ona clinical database projects.
Strategic planning
Talent development
Operations management
Resource allocation
Cross-functional collaboration
Organizational development
Budget oversight
Database development
Cross-functional team leadership
Team leadership
Oracle Clinical, Medidata Rave, Inform, Veeva