Experience

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  Accenture services india pvt ltd

  Jul 2006 - Dec 2007

  Senior process associate

   Interacted with investigators participating in Clinical trials in various therapeutic areas in United States, Europe and Asia-Pacific Regions and helped them in query resolution process Ensured the validity of clinical trial data Designed data collection instruments Managed the flow of data to and from the investigative sites Executed data validation programs and reports to facilitate data review Performed in-house review of CRFs for adherence to protocol requirements and project specific requirements Generated and tracked queries Show less

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  Icon clinical research

  Dec 2007 - Mar 2010

  Cra

   Performed Feasibility Evaluation, Pre study visit and site selection, Site Initiation, Site Monitoring and Co-Monitoring visits depending on project requirements and site close outs. Coordinated inventory management of clinical and non-clinical supplies and performed drug accountability during every monitoring visit. Communicated with external vendors for procurement of trial related supplies. Reviewed Case Report Forms and have an experience on monitoring electronic case report forms for two years. Liaised with Medical Monitors, PIs and sponsors as and when required. Acted as Global lead CTA for Asia Pacific region. Conducted study specific, protocol and EDC training for the new CTAs and CRAs of AP region for prostate cancer study on a regular basis. Assisted Lead CRA in project management. Assisted in Regulatory and EC submission’s for the projects. Conducted all in-house project activities, and providing administrative support to the clinical project team. Prepared, collected, tracked and analyzed of data and/or documentation to produce high quality reports. Show less

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  Ppd

  Aug 2010 - Mar 2020

  One of the key members in setting up the RSMM department as Centre of Clinical Management. Executed the implementation of new model to more than 70 ongoing global studies, recruited candidates, developed first induction plan for the newly established department, Certified Clinical Foundation Programme trainer across APAC, Handled line management of a team size of 40 Plus comprising of 2 Associate managers and 38 direct and indirect reports. Leading the global forum of CCM Centers, maintaining attrition, developing retention plan and mentoring/guiding subordinates and peers to grow in their career. Supported the Remote Site Monitoring implementation to all new and existing projects in PPD by acting as implementation lead and successfully transitioning 70+ studies to new model from 2014-2015. Organized and established a training programme for a newly formed department of 200+ employees. Actively participating in global initiatives to constantly improve the current department processes and explore business opportunities for the department. Leading the global forum for RSMM team for 3rd Consecutive year. Established study plans including Departmental Task Matrix, role specific annual performance goals, employee, study onboarding list as per role, communication matrix, report template review plan, central filing plan, training compliance, performance survey, etc. Recipient of CEO Performance Excellence Award for the year 2017 for contribution in RSMM team. Certified PPD Trainer- Conducted various training sessions of CCM, India and supported the training group with delivery of CFP classes for RSM-Cs and RSM-Ls. Active member of Training and Regulatory Council of ISCR (Indian Society for Clinical Research). Show less

  • Senior Manager-Center for Clinical Management

    Apr 2016 - Mar 2020

  • Manager, Center for Clinical Management

    Nov 2014 - Mar 2016

  • Senior CRA-Level II

    Apr 2013 - Oct 2014

  • Senior CRA-Level I

    Oct 2011 - Mar 2013

  • CRA II

    Aug 2010 - Sept 2011
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  Gsk

  Apr 2020 - Aug 2021

  Study delivery lead (global project manager)

  Global Study oversight following time, budget and quality, using risk-based approach methodology.• Leading a multifunctional team to ensure study Oversight, study delivery and operational decisions are taken at study level.• Develop study management plan including forecast, resourcing,detailed schedule and budget.• Ensure appropriate study oversight including study kick-off meeting(s), regular TC with LOC/CRO, review protocol deviations, escalation process and ensure appropriate follow-up actions are taken.• Coordinate with Clinical Research Development Lead (CRDL), Epidemiologist, Country Medical Directors (for local studies), etc to ensure the appropriate experts (both central and local, operational and medical/scientific) are involved at appropriate stages and outputs are delivered on time• Leading and Overseeing operational activities in study design and study execution including Inputs to concept protocol and protocol development to ensure the optimal operational design.• Accountable to ensure that the study feasibility process and the country/ies allocation is optimal in regards to the project strategy. • Accountable to ensure that the study execution health check is the most optimal in regards to the project strategy. • Ensure functional strategy and plans are developed, maintained and executed includingclinical supplies, sample management, data management, document management, and quality. • Ensures appropriate training of country staff and sites on protocol and project-specific matters • Develop and ensure on-time execution of supportive documents, plans, and manualsincluding the monitoring plan, study procedures manuals, core operational packages for submission.Accountable for the study budget, appropriate documentation of Oversight in TMF• Selection and contract development of Vendors.• Provide input to the clinical study report/module appendix• Ensure Sign-off essential study documents Show less

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  Parexel

  Aug 2021 - now

  • Associate Project Director, Project Leadership

    Apr 2023 - now

  • Senior Project Leader, Project Leadership

    Aug 2021 - Mar 2023