Apr 2022 – Jul 2023 · 1 yr 3 mos

• Owned P&L accountability for key client accounts in Clinical Data Management and Analytics
• Led talent acquisition, onboarding, and capability development, building and mentoring high-performing global teams
• Drove account growth by identifying new opportunities, expanding service offerings, and nurturing client relationships
• Partnered with the Marketing team to shape and promote thought leadership, enhancing the organization’s visibility in the clinical research ecosystem
• Collaborated with Sales and Vertical teams on RFP responses, solution design, and commercial proposals
• Represented the organization in bid defenses, client presentations, conferences, and industry seminars, establishing executive presence and credibility
• Championed delivery excellence through strong governance, quality focus, and proactive client engagement across multiple long-term engagements

Apr 2019 – Mar 2022 · 2 yrs 11 mos

• Led people management initiatives, including hiring, training, mentoring, and performance management of clinical data managers and team leads across multiple geographies
• Directed project management activities, solving complex clinical data management challenges and ensuring consistent delivery excellence
• Collaborated with global delivery managers from the US, EU, and APAC regions to optimize resource management, improve process efficiencies, and build sustainable, scalable delivery models for key clients
• Partnered with Business Development, Solution Design, and Proposal teams to design client-centric, profitable solutions addressing existing and emerging clinical data challenges
• Served as a Subject Matter Expert (SME) for database design, clinical data reporting, process automation, and data analytics services
• Authored and implemented process improvement plans and standard operating practices to harmonize operational performance across global teams
• Led Computer System Validation (CSV) projects for Electronic Data Capture (EDC) tools, ensuring compliance with 21 CFR Part 11 regulatory requirements
• Actively contributed to clinical data standardization initiatives, including building CDASH-compliant CRF libraries for Medidata Rave and IBM Clinical Development (formerly eClinicalOS)
• Acted as the primary point of contact for multiple strategic accounts, advising clients on complex EDC configurations and standardization strategies
• Provided technical consultancy and leveraged SME-level expertise in Medidata Rave URL Administration, Core Configuration Setup, Database Design, and Optional Module Implementation to optimize client solutions
• Delivered capability presentations to prospective clients, showcasing organizational strengths in Clinical Data Management, EDC expertise, and data-driven decision support

May 2018 – Mar 2019 · 10 mos

• Led the Clinical Data Management (CDM) group, ensuring timely, professional delivery of ongoing project management and operational excellence
• Directed initiatives in data visualization for business intelligence and clinical trial analytics, supporting data-driven decision-making
• Acted as a Subject Matter Expert (SME) in pharmaceutical product development, clinical trial operations, and regulatory compliance requirements
• Managed the people development lifecycle, including hiring, training, mentoring, and career progression planning for data management teams
• Designed and proposed innovative, efficient data management and analytics solutions to meet client needs and improve operational outcomes
• Collaborated across all business units, actively participating in sales support, proposal development, and strategic initiatives
• Represented the organization in client meetings, bid defenses, industry conferences, and proposal discussions, strengthening client confidence and industry presence
• Responded to RFIs and RFPs, prepared bid grids, and partnered with the Proposal Team to finalize competitive and compliant proposals
• Assisted in the development of bid defense materials and contributed to scope identification and scope creep management during project execution
• Functioned as a technical SME for clinical database delivery, clinical analytics, and reporting solutions, driving technical excellence
• Led study setup activities for major EDC platforms, including Medidata Rave and IBM Clinical Development (formerly eClinicalOS)
• Authored and reviewed key Clinical Data Management deliverables, ensuring high-quality documentation and operational consistency
• Managed end-to-end customer accounts, including project management, budgeting, client satisfaction (CSAT) monitoring, and issue resolution

Jun 2014 – Apr 2018 · 3 yrs 10 mos

• Served as the primary point of contact for all sponsor communications and acted as the first level of escalation for study-related issues in Clinical Data Management (CDM)
• Led all clinical data management activities on assigned projects, ensuring delivery in a timely, efficient, and compliant manner
• Managed end-to-end study setup, conduct, and closeout activities, including eCRF design, edit check programming, User Acceptance Testing (UAT) execution, Go-Live support, data validation, discrepancy management, database lock, and final data transfers
• Directed cross-functional coordination with internal and external stakeholders, including Clinical Operations, Medical Writing, Biostatistics, SAS Programming, Data Management Vendors, and Medical Coding teams, to ensure seamless data flow and project execution
• Participated actively in study team meetings, providing strategic inputs from the CDM perspective and proactively updating teams on data management milestones and deliverables
• Monitored study progress and provided periodic status updates to sponsors and internal stakeholders, maintaining full transparency and risk mitigation
• Acted as the single point of contact for CDASH implementation, driving the adoption of data standards and improving data capture consistency across studies

Nov 2013 – May 2014 · 6 mos · Pune Area, India

• To lead Scientific Solutions department for RFP/RFI management and solution design to meet client requirements
• To participate in Bid-defense, develop client dossiers and knowledge repository for solution and client services
• To support pre-sales and other Business Development activities
• To be accountable for enabling the client services team to exceed client acquisitions by designing solutions to meet client requirements and supporting key technical areas of the business development process
• Own knowledge management of all client pursuits
• To lead sales and operational support functions for client services
• To provide business development leadership in business solutioning, proposal development process and commercial positioning for Sciformix
• To liaise with multiple stakeholders
• To lead and manage RFx from content development to completion
• To support bid defense of key proposals; including driving pursuit plans, solution strategy, pricing, overall response and deal approvals
• To recommend and implement operational changes that drives asset creation, solution packaging, presentation and financial maturity in deals

Nov 2011 – Nov 2013 · 2 yrs · Pune Area, India

• To provide key inputs to delivery head for accessing and preparing RFPs/RFIs
• To identify the scope and estimate the efforts for Sciformix’s activities in CDM RFPs
• To regularly liaise with client to ensure projects are on the track and billings are up to date
• To identify scope creep and bring it to management’s notice for updating current contract
• To perform various activities in the area of clinical data management and manage assigned project/s to deliver timelines and quality by effective coordination between internal and external customers
• Responsible for performing various activities in the areas of Clinical Data Management and facilitating compliance to all applicable SOPs, regulations with regard to the conduct of CDM operations
• To implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures
• To ensure compliance of operations with governing regulatory requirements
• To create, maintain and assume accountability for a culture of high customer service
• To deliver various data management services e.g. Authoring and Review of Data Management Plan, Authoring Data Quality Specification document, Data Entry Guideline document etc.
• To proposes alternatives and solutions for improvement in quality of work
• To possess understanding of data management budgets and can communicate out of scope requests to delivery head

Aug 2009 – Nov 2011 · 2 yrs 3 mos · Pune Area, India

• Data Validation:
• Responsible for the successful execution of the clinical data management projects as lead CDM with minimal supervision for several midsize to complex projects/partnerships
• To create, review and process Data Clarification Forms/Answered Queries and updates the databases
• To ensure the query to the site is clearly worded and add clarification if needed. If query can be resolved without response from site then to ensure data are updated internally
• To ensure site addresses query by either, answering the query, or updating the data
• Regularly liaises with monitoring, database programming, medical coding and statistical programming teams to ensure smooth functioning of a study
• SAE Reconciliation:
• To ensure SAEs are reconciled according to edits between the clinical database and Sponsor’s Safety System also to ensure consistency between the fields in the databases
• When inconsistencies are found then to query the site to confirm which data are correct
• To submit an Sponsor Safety System Change Request Form when needed
• Central Lab and ECG data Reconciliation (Third Party Data)
• To identify Lab and ECG discrepancies between central lab database and clinical database and to submit lab fixes to appropriate vendor to resolve data discrepancies in the central lab and ECG database
• To verify the central LAB and ECGs are mapped to appropriate visit with respect to collection date and corresponding date of visit as mentioned in study specific guidelines. To submit lab fix if any discrepancy exists
• To verify central ECGs are performed at defined protocol timings and to report any irregularity/inconsistency to CDA at client
• To verify before study completion data lock and other snapshots (if applicable) that all lab fixes have been completed

May 2009 – Jul 2009 · 2 mos · Hyderabad Area, India

• To annotate CRFs in accordance with NHPL specific guidelines
• To create and program data sets and data programming specifications per specified study requirements
• To validate data sets and to create and maintain study documentation as required
• To execute programs and generate clinical data outputs according to study requirements
• To participate in testing of clinical data system upgrades and documenting of test scripts when required
• To manage programming and validation activities across a single project, ensuring that timelines are met and deliverables are of sufficient quality

Jan 2008 – Apr 2009 · 1 yr 3 mos · Mumbai Area, India

• To supervise a team of 12 associates responsible for performing UAT of EDC (Rave) and Paper trials
• To perform line management activities to guide and counsel direct mentees on their career development
• To allocate resources on projects considering the timelines and requirements by Client
• To motivate team members by team building activities
• To identify and develop action plan for DM’s not meeting the client SLA’s
• To coordinate between the DM and Sponsor for all project calls
• To identify areas of concern within the team and train/re train people as and when required
• To provide input on individual performance during appraisals
• Was a member of clients offshore DATA STANDARDS team
• To identify and build new modules, variables, sections for CRF and edit checks and request DATA STANDARDS tea, to approve them to be used in similar upcoming studies

Feb 2006 – Jan 2008 · 1 yr 11 mos · Mumbai Area, India

• To clinically examine the patients and to determine the cause of the illness
• To prescribe a herbal treatment to clinically ill patients to remedy the effects
• To provide preventive care to the patients by prescribing periodic health check ups, appriproate diet consultation and suggest lab tests to ensure the vital body systems of patient are doing well