Arpita Patel

About Arpita Patel

Professional individual with years of experience in healthcare and a candidate with thorough knowledge of Clinical research and Drug development process, Regulations, Guidelines and Standards in CDM, Data tracking, validation, transfer and coding guidelines. SAE reconciliation and data collection in clinical trials along with designing CDM database and Case Report Forms.I am proficient in maintaining professional relationships and have certification for clinical data management. • Trained in Interpreting protocol, creating DMP, designing CRFs and test scripts. • Excellent knowledge and understanding of electronic data entry, data cleaning and source documentation verification (clinical monitoring).• Trained in end to end clinical data management activities like in study start up, Interpreting protocol from data management perspective, Designing mock CRF hands on as per CDASH, doing visual form completion guidelines, Writing edit check and Manual checks, Performing data entry for edit check UAT and documenting the issues in UAT test log. Writing data management plan, drafting data transfer specification in case there is a non CRF component like external data element (IVRS, PK, Labs, ECG etc.)• Performing discrepancy management during the study conduct phase including reconciliation of external data and safety data reconciliation as per DMP.• Experience in closing database per database lock checklist like assessing the volume of data entry left, number of open queries, amount of external data to be reconciled, number of data points to be monitored by the CRA, number of verbatim terms to be coded and QCed.• Maintaining Study document in TMF from audit perspective.• Experience working in clinical settings coordinating with Physicians and other medical personnel.• Exceptional leadership, organizational, oral and written communication, interpersonal, analytical, and problem resolution skills

Experience

1. Senior Country Approval Specialist

   Ppd

   Aug 2022 — Present

Education

• Rajiv Gandhi University of Health Sciences

  Bachelors, Bachelors of physical therapy

  2003 — 2008