Arpit Malik

Experience

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  Novartis

  Aug 2017 - Apr 2022

  - Ideally more than 3 years experience in Data management.- Providing timely and professional ongoing management of clinical trial data with respect to quality and timelines for assigned trials managed within Clinical Data Management. Ensure high quality data available for analysis and reporting.1) As I am working as Clinical Data Manager (CDM) and provide data management input on Clinical Trial teams. Sometime have to role of TDM on small low complexity trials for Individual activity.2) Performs DM activities for start up of a study including preparing the eCRF (Identification of CRF), CCG’s (CRF Completion Guideline), SSD (Study Specific document), ECS (Edit check specification) where needed, Data Handling plan (DHP) Data Review Plan (DRP) and performing user acceptance testing (UAT).3) Understand third party data requirements and learn to gather an understanding of data that will be used in the course of clinical trials.4) Performing ongoing review of all data generated from the clinical study including Third party and local lab data as well as SAE reconciliation where applicable.5) Ensures activities that are performing with quality and understanding of the process.6) Verifying and tracks eCRF completion including Query resolution and provides data status updates as needed.7) Giving my suggestion to Trial Data Manager for resolve issues, that is occurring during the running of assigned trials.8) Working knowledge of ICH (International Conference on Harmonization) guidelines.9) Has ability to use the tools (J-review, Rave X) available to generate listings for data review and where necessary, provides these listing to the study teams. Generates the study status reports for use at Clinical trial team meetings. Show less

  • Clinical Data Manager

    Apr 2019 - Apr 2022

  • Associate Clinical Data Manager

    Aug 2017 - Mar 2019
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  Novartis India

  Apr 2022 - now

  Senior Clinical Data Manager

  1. Working as a Senior Clinical Data Manager for NIBR trials and handling the study independently as a Lead Data Manager.2. Provides feedback to assure well written protocols and resolve protocol issues that may impact database design and data reporting. 3. Well versed with RAVE.4. Performs DM activities for start-up of a study including preparing the eCRF, CRF Completion guidance (CCG’s), Data Handling plan (DHP), Data Review Plan (DRP), performing user acceptance testing (UAT), Edit check Specification (ECS), Study specific document (SSD), Data Transfer Specification (DTS).5. Disseminates study level information to the Clinical Trial Team (CTT).6. Supports and assists Junior staff for assigned trials.7. Is responsible for Query Management and Performs DM hands on activities during the course of the study.8. Ensures Third party and other necessary reconciliation activities are performed for the study in a timely manner.9. Worked in various Set up studies as User Acceptance Test support.10. Also performed Postproduction change (PPC) after Protocol amendment.11. Worked in interim and final DBLs for various trials.12. Involved conduct as well as lock activities.13. Also supported Setup trail to work with Identification of CRF, Raised SRF and made draft of all related document (SSD, CCGs, ECS ETC).14. Provides effective input into DM initiatives and innovations for quality, efficiency, and continuous improvement in scientific and operational excellence.15. Tracks and reports status for assigned trials to ensure milestones are met with quality.16. Ensures to touch base DM standards, SOPs and process guidelines throughout the Study. Show less