Jigyansha Sandha

Organized and goal-driven Clinical Data Management (CDM) professional with 4.5+ years of experience in managing clinical trials database, RAVE EDC, Medidata, Query Management, Validation Check UAT, Edit Check and Database UAT, SAS Listing UAT. Responsible for performing all clinical data management activities, discrepancy management, clinical data review, and database lock activities for various clients including Rave external.

Clinical Data Specialist - IQVIA - Bengaluru

(2025-04)

• Conducted Clinical User Acceptance Testing (UAT) in the RAVE Database, ensuring system accuracy and functionality.
• Performed UAT for Edit Checks and Custom Functions, validating compliance with study specifications and regulatory standards.
• Executed database validation for both initial study builds and post-production changes, maintaining integrity throughout study lifecycles.
• Developed and created test cases based on predefined logic, verifying data outputs and troubleshooting discrepancies.

Senior Clinical management Associate - Accenture pvt ltd - Bengaluru

(2021-03 - 2025-03)

• Proficient in managing clinical databases (e.g., InForm, iMedidata Rave, Veeva Vault) for multiple clinical trials.
• Worked on SAS checks and other Manual Checks (DRT Checks), Resolve Data Clarification and review the data as per Study team requirement.
• Performed Vendor data reconciliation, and worked on Vendor issue log for the follow up.
• Familiar with regulatory guidelines such as ICH-GCP, FDA, and EMA for maintaining clinical trial data in accordance with industry standards.
• Expertise in validation to ensure data accuracy, completeness, and integrity.
• Work on review and approval of Specification, Archival and approval of all documents in repository.
• Creates and maintains / perform User Acceptance Testing (UAT) procedures for Electronic Data Capture (EDC) systems. Coordinates and manages EDC and UAT related efforts within the department and across different functional areas.
• Collaborated with cross-functional teams to support clinical trial activities, ensuring timely and accurate data reporting.
• Applied strong problem-solving skills to resolve discrepancies and data-related issues, ensuring smooth trial execution.
• Experienced in study closeout activities (Database Lock) and study conduct (Interim Analysis)
• Project Management to ensure the timelines for the study release have been met.
• I work as a POC of the study trials i.e. (monitoring data flow, managing discrepancies, and overseeing all other data management processes) for all the stakeholders involved in the study.
• Support process improvement project support develop deliverables for PDAM-NG studies using Next generation tools like DMW and LNMT.
• Supporting CDM with specification review and performing Quality-Integrated and PDAM-NG process.
• Helped identify and raise protocol deviations in databases, perform edit check validation by creating test cases, write test scripts and carry out database validation against specified eCRF.

Masters in Science - Bioinformatics - Utkal University (2019 - 2020)

Bachelors in Science - Bioinformatics - Utkal University (2015 - 2018)