Prashant Kumar, Mca, Ccdm® Email & Phone Number

Pune, Maharashtra, India

20 years of exp. working as Delivery Partner & SME (Domain, Techno Functional Consultant) and managing multiple pharmaceutical accounts in the area of IT AMS / Bio-Statistics & Clinical Data Management (BDM) in Life Sciences domain.

Mumbai/Pune

Excellent technical & functional knowledge on Clinical Trials end to end, Clinical Operations and Clinical Reporting Life Sciences Advisory – Multiple Life Sciences consulting projects which include Process Maturity assessment & designing the envisioning state, guidance on Operations strategy, performance improvement and KPI definition. Completed product evaluation and benchmarking of Oracle’ Clinical One with Industry leading CDMSs. Worked on various solution designs and RFIs/RFPs across IT, Platform and BPS as a Techno Functional SME, Life Sciences.Domain consulting, Transition management, Supporting pre-sales for RFIs and RFPs,.ITIL , Service-Now, Remedy, Incident Management, IMPACT CTMS, SMART, CTRUE Oracle certified InForm, Central Designer Clinical One professional. Trained and certified in Veeva suite of products like CDMS, CDB, Vault etc.

Mumbai/Pune

Experience in managing Application Support services teams in Clinical Development and Medical Affairs areas using and strong Oracle PL/SQL knowledge Application Support and Maintenance experience with knowledge in IMPACT CTMS, SMART & CTRUE systems # Oracle PL/SQL, DB refresh Manage day-to-day Application Support operations for IT applications Generate periodic (weekly/monthly) support metrics and SLA compliance Manage Minor/Major Enhancements. Participate in weekly/monthly status and performance review meetings Experience in configuring, trouble shooting and debugging Clinical Trial Management System applications including servers, databases and other applications Manage delivery during the Transition especially at the early stages of the project Ongoing interactions with accounts to ensure quality issues. Support QC Compliance/Regulatory Compliance.

Pune Area, India

Internal/External Customer communication• Organize and Participate internal/External kick off meetings• Participate in Client, Vendor and team meetings• Identify changes in scope and liaise with Project Leader• Establish efficient / effective working relationships with other project leads and coordinators• Identify and resolve issues and conflicts within the project team.Budget/Finance/Resource planning• Early recognition of areas of potential problems and provide input to contingency plans, providing Domain consultation.• Evaluate and identify resourcing needs and continuously monitor over life cycle of project• Provide Revenue forecast & revenue recognitions to the finance team• Draft and submit budget proposals, and recommend subsequent budget changes where necessary.• Participating in Bid proposals, and Bid defense• Working closely with Senior Leadership Team (SLT) to ensure and achieve the appropriate Utilization and Realization targets.Domain Specific responsibilities• Act as technical resource for InForm Architect/Clintrial/Oracle Clinical and/or SAS data programming. EDC and architecture Implementation.• Participate in the development and maintenance of programming guidelines and standard procedures.• Provide training to clinical data programming group and Data Management department.• Participate in Data Management department initiatives.• Administrative responsibilities include projecting, planning and tracking of projects, resource allocation, and supervision of programmers, medical terminologists, and/or forms designers.• Assign tasks and follow-up on tasks assigned to programmers.• Ensure programming processes are compliant with applicable SOPs.

Pune, Maharashtra, India

/From - To Roles & Responsibilities; Review and annotate CRFs in accordance with defined database standardsDesign databases and data entry screensTest and maintain databases and data entry screensSetup Medical coding and CRF Tracking Reviewing and suggesting project specific guidelinesCreating edit checks and Validation testing Deployment of quality control checklists & templatesPerforming QC on the clinical databaseTracking study status reports & progress updates ( backlog, supply etc)Mentoring new team members on CDM activitiesProgram discrepancy checks using PL/SQL codeTest and maintain discrepancy checksImporting and exporting data filesAssist with creating, testing, validating database systemsAssist with development of departmental guidelines in line with database set-up and standards

Chennai Area, India

Performing the various study start up data management activities like setting up a clinical database, Global library management, CRF designing, creating and testing procedures, creating and testing entry screens etc in InForm* Architect.Form Tech Reviews, Rules Development in VB Scripting, and XML, Estimation, Work Allocation, tracking deliverables and defect prevention activities, UAT & Change Request & Supporting Testing Team to carry PAT (Pre Acceptance Testing).Proving SAS programming support to the clinical team.Training the team members in the space of Clinical Trial and Data Management and InForm* Architect applicationParticipating in business teleconferences Building up Study as well as mock databases