Domain SME CDM & Solutioning lead. Delivery Head for one of the world’s top 3 Pharma engagements with service delivery of Clinical Database Programming & Reporting, Clinical Data Management, Biostatistics & Programming.Responsible for 3 Tier Governance, Operational Steering Committee, Executive Steering Committee. Overall managing a department of 150 Plus associates, of Clinical Database Programming & Reporting, Clinical Data Management, Biostatistics & Programming functions.

Was leading Global Database programming function and a Global Client partnership with functions : Clinical Operations, Database programming, Data Management, Biostatistics & Programming, Medical Writing and R&D Scientists.

• Heading a department of Clinical Data management and Shared services and responsible for managing delivery of Clinical Data Management projectsManaged all processes within CDM. Which includes. Data management (Set up, Conduct and Closure), Medical Coding, SAE Reconciliation, Third party/Lab data management (Vendor data), CRF Designing.• Heading the group with a Span of control of 100Plus FTEs and P & L responsibility of large CDM partnership • Project management and service delivery of CDM projects• Client management and Revenue management• Represents in Governance meetings.• Participates in engagement level risk review meetings and responsible for escalation management system• Managed a client partnership for a second largest global pharmaceutical company

• Set up Operations for SBU in India, Clinical Database programming• Designed strategic plan for transitional, implementation, stabilizing and delivery of project accounts for global pharmaceutical clients• Managed large global client accounts, for resourcing, project management, quality, delivery and budget management. Presently leading the same with global studies & a data management centre in Hyderabad • Operational/people management with over all leadership and delivery expertise in CDM tools Inform, OC ,OC-RDC, SAS,IMPACT-CTMS,DATALABS,ARGUS-Phramacovigilance tool.• Represented and participated in bid defense meetings and due diligence assessments for new proposals/client contracts and had won, one of the largest and unique offshore deal for PAREXEL• Had successfully done the transition of Data management and programming process and projects for global sponsors. From an onshore unit to offshore unit, Hyderabad• As an operational head represented client audits by world’s largest pharmaceutical company on process and systems of Clinical Data Management. And had zero findings on the audit report. Received a citation of appreciation from the client• Directly managed senior managers, managers and Ass.Managers .With a dotted line responsibility to technical leads, SMEs and Project management. • Domain expertise Clinical Data Management, Global project management including P& L for giant pharmaceutical clients • Had traveled extensively and has Operational experience in working directly with business cultures across the world, US,UK,Germany,South Africa, France,Japan,China,Taiwan.• Had developed Global Business continuity plan (BCP)/Disaster recovery plan(DRP) for the CDM business unit

• Certified to validate clinical research data in Global clinical database.• Data Validation and Discrepancy resolution• Clinical data management per protocol. – Handled the database of a phase II and phase III clinical trials that are multicentered double blind randomized placebo-controlled studies.• Validation and resolution of Manual, Electronic and System generated discrepancies• Mentoring new Data validation associates. • Coordination with the research site (On shore) and Clinical research associate• Data Clarification Forms and Site monitor generated Data Clarification Forms creation and integration.• Thesaurus management system for coding adverse events and medications.

• Medico Marketing Specialty products (Respiratory and Pediatrics and ENT)• Scientific promotion