Dr Aditya Mishra, CCDM®

Experience

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  Bharati Hospital and Research Centre

  Jun 2012 - May 2013

  Pharm D intern

  Worked as Clinical and Hospital Pharmacist in Bharati Hospital with the following job description:• Department of Gynaecology: Patient history interview, Counselled pregnant women regarding significance of taking iron supplements and healthy diet during pregnancy, Analyzing adherence behavior, Monitored side effects and Complications associated.• Department of Paediatric: Paediatric divided dose dispensing, Patient interview, Medication Counseling, Analyzing adherence pattern, providing evidence based Drug information.• Department of Medicine: Drug therapy monitoring, identification of DRP’s ADR’s, potential drug interactions, patient history interview, medication counseling, drug information to the patients, healthcare professionals and to the general public.• Pediatric vaccination trials: Observational Experience in overseeing trial activities. Gave helping hand for: Renewal of Ethics committee SOP, Diary filling to subjects, Patient counseling, summary report of Ethics committee meeting, Filling entry logs of expenditure, Filling wages voucher, Checking diary entries, Source data verification (SDV). Show less

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  Tata Consultancy Services

  Apr 2013 - Nov 2014

  Senior Process Associate

  Worked as Clinical Data Manager in Oncology Project, Tata Consultancy, Mumbai as Senior Process Associate- Data Management.* Worked on InForm Database and Exact tool* Reviewed and understand the study protocol and the time-lines. * Aware and updated of the sponsor’s quality standards and undertake any relevant training for the same if required.* Escalated discrepancies in the clinical data to the DM study manager as appropriate.* Performed external checks to handle manual discrepancies and action the same* Worked on manual listings (Conmed Vs AE Reconciliation, Blood Product Vs AE Reconciliation, subject’s tracker etc). * SAE Reconciliation to review and clean the safety data.* SAE Alerts Notification * Contact monitor to assist site to ensure high quality and timely update eCRF.* Performed DBR for allocated studies in timely and effective manner to achieve the timeline of study.* Prepared eCRF guidelines for Oncology study.* Prepared Guidance documents for activities like SAS checks, Metrics Reports etc.* Locked database on timely manners as per timeline to achieve the DBR and DBF.* Preparing trend analysis for sites.* Data transferred to statistician for interim statistical analysis. * Prepare Study Metrics and sent to Monitors.* Local Lab reconciliation.* Running SQL.* Prepared eCRF guideline for a oncology study.* Running various client specific tools to process external data, performing data tools loads, deliverables via External Alliance portal (EAP), External Data Utility (EDU), EXACT, SPECTRE to perform data reconciliation process.* Hands on various Client specific tools.* Reviewed the resolved discrepancies and close where appropriate* Ensured an error free, quality data with no open queries.* Attended relevant study teleconference with the sponsor’s staff.* Coordinated with the sponsor’s CDM study manager with respect to any unresolved queries and close the same* Suggested Metrics improvement. Show less

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  Cognizant Technology Solutions

  Nov 2014 - Oct 2015

  Junior Data Analyst
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  IQVIA

  Oct 2015 - Jul 2022

  - Handling individual portfolio studies for client as a lead for operational staff.- Managing End to End study as study Sr DOC (Data operating coordinator) for more than 4 studies with leading to operational staff (CDC) excludes DE.- Effectively and timely delivered quality data as per DBL plan- Leadership role in a specific area or process on a large study with guidance- Serving role of Data Operations Coordinator & Vendor SME- Conduct data review for allocated studies as per DMP document- Contribution to develop new edit checks in SAS library - Develop and test databases and edit specifications- Develop and maintain good communications and working relationships with CDM team- Routine work assignment to team as per DMP- Involve in meeting with Sponsor for critical decision pertaining to operations- Regular communication with DTL for the study planning- Support to Other DOC in critical situation for their studies- Create monthly quality reports and share with team on monthly basis- Suggested and implemented for knowledge sharing session for entire team- Monthly QC for team for allocated studies- Post production changes as per team decision and assured for its completeness.- Timely communication with Vendor for the issues and for the process updated if any- Documentation of study document in respective repository. - Prepared and Implemented SAE quality reviewer process to identify qualified SAE reviewer to maintain the quality. Show less

  • Data Team Lead

    Mar 2021 - Jul 2022

  • Asso Data Team Lead

    Sept 2019 - Mar 2021

  • Senior Clinical Data Coordinator/Back-up Data Team Lead

    Apr 2017 - Sept 2019

  • Clinical Data Coordinator

    Oct 2015 - Mar 2017
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  Syneos Health

  Aug 2022 - now

  Sr Project Data Manager