Prem Kumar Email & Phone Number

Charleston, South Carolina Area

• Ensure the contracted data management services for clinical studies are carried out in accordance with the executed contract, Sponsor and relevant regulatory agency specifications. • Coordinate and oversees the work of the data management team and collaborates with clinical, biostatistics and executive management to achieve quality goals and project specific timelines. • Oversees the work of the DM team and review specific work, that filing and reporting requirements are being met. Analyze and define data requirements and specifications for clinical studies. • Provide guidance to the database programming group through various study data management activities including support and maintenance of clinical databases. • Develop CDMS related SOPs, write, review or approve Technical Manuals/ procedures for clinical programming. • Assure clinical databases are built to conform to company standards in order to facilitate the use of the data in the regulatory process. • Oversee creating, maintaining and archiving data management documents. • Responsible for the creation and execution of clinical study database. Manage database maintenance and support. • Collaborate with study team both external and internal to develop / manage the development of case report forms. • Oversee the establishment of data validation rules and Supervise the implementation of data validation checks and derivation procedures and all related documentation. • Standardize and enhance the reusability of CDMS library objects. • oversee maintenance of clinical databases according to change control procedures. • Represent the DM staff in cross-divisional initiatives such as CRF template design, clinical web site development, electronic data capture, etc. • Responsible for the development and implementation of methods to ensure high level of quality in DM deliverables.

Hyderabad

• Project Management of Clinical Trial Data Management Activities.• Management of Clinical Applications and Database Administration.• Analyzing and defining data requirements and specifications for Clinical Studies.• Guiding the clinical programming group through various study data management activities including support and maintenance of clinical databases.• Develop CDMS related SOPs, write Technical Manuals/ procedures for clinical programming.• Create Clinical databases which conform to company standards in order to facilitate the use of the data in the regulatory process.• Define, program, and test validation checks and created corresponding documentation.• Responsible for clinical study databases.• Work with Clinical Research staff to develop / manage development of case report forms.• Establish data validation rules. Supervise implementation of data validation checks and derivation procedures.• Standardize and enhance reusability of CDMS library objects.• Maintain clinical databases according to change control procedures.• Represent Data Management staff in cross-divisional initiatives such as CRF template design, clinical web site development, electronic data capture, etc.

Gurgaon - Chennai

• Handled a role of IT and assisted CDM activities. Handled complete system administration activity of Clinical data management along with Company Infrastructure activities.• Handled a team of 10 Members and I was reporting to the CEO of the company. • Lead IT Department operational and strategic planning, planning projects, and organizing and negotiating the allocation of resources. • Providing senior level systems engineering and administrative support across a wide array of software and hardware systems and components used to deliver business and financial services. • Manage the deployment, monitoring, maintenance, development, upgrade, and support of all IT systems, including servers, PCs, operating systems, hardware, software, and peripherals. The following projects were implemented under my guidance : • SAS Foundation (Complete Installation including validation like Project Plan, IQ/OQ/PQ, User requirement, Requirement matrix, validation summary, traceability Matrix etc.)• Completed AERS 4.5.0 TO AERS 4.5.1.21 Up gradation.• Backup and Restoration of Oracle Clinical and Adverse Event• Disaster Recovery and Business Continuity Plan for IT• Developed, implemented and managed Backup and Restoration of Production and Database Servers.

Chennai

Bangalore

Bangalore

Bangalore

Bachelor’S Degree, Computer And Information Sciences And Support Services

Diploma In Computer Science, Computer And Information Sciences And Support Services