Experience

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  Doon paramedical college

  Jan 2010 - Dec 2010

  Lecturer
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  Idd research solutions inc (former i5 clinical research pvt.ltd)

  Oct 2011 - Dec 2011

  Trainee clinical research coordinator

  •Assist in site selection to meet the commitments of subject recruitment and data quality•Screened potential patients for protocol eligibility, Presented trial concepts and details to the patients, participate in the informed consent process, and enroll patients on protocol.•Responsible for accurate and timely data collection, documentation, entry, and reporting.•Interaction:- Regular and timely interaction with Sponsor, CDM’s, clinical lead, Site/Study.•In collaboration with the physician, reviewed patient for changes in conditions, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly document all findings.•Collaborated with Research Site Leader in the study selection process.•Responsible for compiling and reporting protocol activity, accrual data, and research financial information to practice administration and physicians.•Manage the shipment of all clinical trial supplies, responsible to ensure adequate and comprehensive training to sites, ensure effective site initiations and training, & assist in execution of all site level budgets. Show less

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  Cognizant

  Apr 2012 - Jul 2013

  Tjda, data management

  •Support Trial/Lead Data Manager in all Clinical Data Management activities and work as per SOPs, Work Instructions, Business guidelines, Study Templates, Study Master File, and help in Audit Preparation. •Conducted numerous knowledge sharing sessions and groomed other team members in project. •Understanding of full life cycle of CDM from Database Setup/ Start up phase, through Database Conduct/ Ongoing Management up to Database Lock/ Project Closeout phases as follows:Set Up : Reviewing Protocol, Writing and reviewing specifications for eCRF/Paper CRFs for CRF designing, preparation of T & E schedule, Creating and reviewing DMP documents (Data Entry Guidelines, Data Validations guidelines, Data Transfer Guidelines etc.), Writing Edit Check Specifications, Testing (UAT) for Screens and Edit Checks.Conduct: Query/Discrepancy Management, DCF update/Review process, Manual Review, SAS Listings Review, Basics of Medical Coding, SAE Reconciliation, (3rd party Vendor, External Data) Reconciliation- (ECG, IVRS, LAB) .Lock: Checking CRF completion (missing data items/missing pages) & SDV, Critical QC and Sample QC, Freezing and Locking (Soft Lock and Hard Lock), Data Transfer. Show less

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  Clinasia labs pvt. ltd. ( a maxisit group company )

  Jul 2013 - Dec 2013

  Clinical data analyst

  Creating edit checks in RaveMedical Coding / Clinical Data Management

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  Tata consultancy services

  Jul 2014 - Aug 2018

  Act as a primary point of contact to sponsor once the project starts , effectively managing the client expectation and all to and fro communication.Proactive escalation to management of the challenges and scope, ensuring the timelines are met with effectiveness.Planning and supervising to evaluate the lined up activities.Training and mentoring of new hires.Experience in handling Phase I to III studies.User Acceptance Testing (UAT)Experience in discrepancy management and data validation procedures. Manual data review.Responsible for Sample reconciliation, SAE Reconciliation and AE reporting.Handling queries related to Medical Coding.Checking CRF completion, Critical QC and Final Inspection QC, Freezing and Locking. Show less

  • Business Process Lead

    Jul 2017 - Aug 2018

  • Senior Process Associate

    Jul 2014 - Jun 2017
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  Iqvia

  Aug 2018 - Sept 2019

  Associate manager

  Strategic planning and execution of the business model and growth in the field of Lab Database set-up and provide timely feedback to all stakeholders.Develop sponsor specific documents and configure database as per the clinical protocol requirements being responsible for the entire life cycle of set-up project.Perform the verification checks to ensure the database is set to meet client expectations.Plan, prioritize and understand the individual and team requirements and accordingly liaise with Client for trouble shooting. Show less

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  Global clinical trials (gct)

  Nov 2019 - Oct 2020

  Clinical data manager

  •Review staffing for data management activities.•Provide training of other DM staff on project specific processes.•Preparation of Edit Check Specification document and CRF Completion Guidelines.•User Acceptance Testing/Discrepancy management/SAE reconciliation.•Maintain documentation for the project such as Data Management Plan along with supporting DM documents, such as CRF Completion guidelines, Data Entry guidelines, Edit specifications etc.

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  Parexel

  Nov 2020 - Jan 2023

  Study team lead

  •Lead the clinical study activities on assigned projects. •Data Management Lead (DML) tasks: Serve as a single point of contact for all sponsor communications and first level of escalation for any issues. Coordination with other teams/vendors to get the expected task completed on time. Schedule/attend the sponsor meetings and share Meeting Minutes thereafter. •Perform and/or support the setup of DM documents and ensure proper documentation as per Standard Operating Procedures, ICH/GCP Guidelines.•Provide relevant on-the-job training to staff and project teams as appropriate and act as mentor for other clinical data analysts.•Subject Matter Expert (SME) for User Acceptance Testing (UAT) and sponsor specific systems/portal.•Creation of Edit Check Specification and support setup of other DM documents (SAE Reconciliation Plan, Data Management Plan, CRF Completion Guidelines). Data Validation and Testing. Show less

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  Atorus

  Mar 2024 - now

  Principal clinical data manager