Experience

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  Max neeman international

  Jan 2005 - Jan 2006

  Validation associate

  As an acting LDM (Lead Data Manager) for 2 projects•Lead a team of 6 people.•Created Project specific Documentation.•Training the team for different project activities.Database Design, Creation & Validation of Clinical Data Using PHEEDIT Ver 3.0•Module creation, Variable creation, Validation Check creation, Database lock and Data Export to SAS for analysis.•Creating Validation Checks in the database design to check the discrepancies in the clinical data.•Data Handling and data log maintenance.•Actively involved in giving Presentations regarding different Data management Activities.•Developed Annotation Code Book for Neeman Medical for escalating the process of CRF annotations. Show less

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  Tata consultancy services

  Jun 2007 - Jan 2010

  Team lead [clinical data validation]

  Designation: Process ExecutiveRole: Team Leader (Clinical Data Validation)Notables:As a Team Leader handled a team of 10 Clinical Data Validators and managed 31 EDC studies in different therapeutic areas including Oncology. Performed the following activities:• Team Management.• Performance Evaluation and Appraisals.• Designing Growth Plan for the team members.• Internal process trainings.• Data Validation (Query Management) using INFORM 4.5.• Data Synchronization between INFORM and Clintrial.• Interactive Coding of Medications using WHODrug Dictionary integrated within Clintrial.• SAE Review using INFORM Report and SAE Database Report.• SAE Reconciliation using INTEGRATED REVIEW (I-Review Report) in Clintrial.• Quality Review of the Clinical Data. Show less

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  Inventiv health clinical

  Feb 2010 - Dec 2011

  Study data manager

  Designation: Study Data ManagerRole: Clinical Data ManagerNotables:• Work across international and functional boundaries as needed within a project team environment.• Work closely with Clinical, Medical, Statistics and Data Management team members.• Work closely with study Statistician, Clinical Operations team for CRF designing.• CRF Designing using ADOBE FRAMEMAKER 6.0• Review Annotated CRF. • Prepare, maintain and ensure the execution of Data Entry guidelines, Discrepancy/Edit Check documents, Quality Control Plans• Test and approve data entry screens.• Test and approve discrepancy/edit checks.• Track CRFs using electronic systems as required.• Discrepancy/Query Management.• Communication with clinical sites to resolve outstanding data issues.• Sign off on Database. • Manage/Facilitate Final QC Activities.• DB Lock/Unlock Activities.• Creating the signature forms (Data Entry Receipt Log, Study Signature Log) • Maintaining Study Binder.• Managing Study Timelines.• Attend and participate in project team meetings. Show less

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  Cognizant

  Dec 2011 - Oct 2013

  Contingent workforce coordinator

  Designation: Associate, Data Analysis Role: Contingent Workforce CoordinatorNotables• Managing an on-site/off-shore model.• Point of contact for communication and work for off-shore to non-trial specific activities (such as communication related to Training, sharing of Best practices, announcements).• Understand project needs and articulate effectively to off-shore team.• Manage and report resource utilization / calculation.• Responsible for training compliance.• Responsible for on-boarding of new hires.• Budget and resource forecasting and tracking of actual.• Performance measurement (breakdown into SLAs- Proposal and FU).• Invoice Management.• Contract Management.• Process Improvements. Show less

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  Syneos health clinical solutions (previously inc research/inventiv health)

  Nov 2013 - Sept 2021

  Associate director clinical data management
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  Syneos health

  Sept 2021 - now

  Director clinical data operations

  •Strategic Portfolio Oversight: Strategically manage diverse FSP (Functional Service Provider) portfolios to optimize operational efficiency and ensure alignment with organizational goals.•Dynamic Vendor Management: Spearhead effective vendor partnerships to enhance service delivery and drive cost efficiencies.•Business Unit Establishment: Successfully supported PMO to establish and scale business units, ensuring seamless integration into existing frameworks.•Efficient Transition Management: Experience driving the portfolio transitions ensuring smooth transitions in project phases, with minimal disruptions and maximum productivity.•Resource Allocation and Oversight: Skillfully plan and manage resources to meet project demands and optimize team performance.•Comprehensive Clinical Data Management: Demonstrate end-to-end expertise in clinical data management processes, ensuring data integrity and regulatory compliance.•Team Engagement and Collaboration: Proactively engage teams through initiatives that foster collaboration, innovation, and professional growth.•Organizational Leadership: Lead and actively contribute to organizational initiatives, driving initiatives that propel growth and innovation.•Global Team Leadership: Effectively manage a diverse team of 150+ professionals across India, EU, and North America, fostering a culture of excellence and collaboration.•RFI and Estimation Management: Actively participate in responding to RFI inquiries and providing ballpark estimations for clinical data management function.•Performance Evaluation: Conduct performance reviews and provide constructive feedback to drive continuous improvement and excellence within the team.•Compensation Planning: Responsible for annual compensation planning, market corrections and hikes for the team.•Project Delivery & Quality: Responsible for overall portfolio deliverables and quality. Show less

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  Syneos health

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  Director clinical data operations