Sonalipsa Padhi

About Sonalipsa Padhi

Fortrea (formerly part of Labcorp Drug Development), Bangalore Jan 2023 – PresentKey Responsibilities:• Managing end-to-end clinical data management activities for global clinical trials.• Performing data cleaning, query management, and data review in accordance with protocol specifications and regulatory requirements.• Collaborating with cross-functional teams (e.g, Biostatistics, Clinical Operations) to ensure timely database delivery.• Supporting database lock activities and post-lock deliverables.• Contributing to the development of Data Management Plans (DMPs), edit checks, and quality metrics.• Participating in internal audits and compliance reviews to ensure adherence to SOPs and GCP. IQVIA, Bangalore Nov 2018 – Dec 2022Total Experience: 4+ yearsKey Achievements & Responsibilities:• Led 3 studies as a DOC (Data Operations Coordinator), overseeing all DOC activities and resolving reviewer queries.• Performed query management, data cleaning, and validation checks based on QDR (Query Detailed Report).• Flagged Important Protocol Deviations (IPDs) using study-specific IPD lists and QCT (Quality and Compliance Tool) reports.• Reviewed key data points: SAS Listings, Inactivated Pages, Missing Labs, Duplicate Pages, Unsubmitted Data Points, etc.• Worked on Post-Lock Activities (PLA) including hyperlinking and preparation of submission-ready PDFs.• Managed EDC forecasting/tracking, data review referencing DMPs and eCRFs.• Worked in various database environments including i-Medidata, Medidata Rave, and MDSOL.Areas of Experience:(Oncology, Virology and Hematology studies): • Review of SAS Listings, Inactivated Pages, Unforecasted Unsubmitted Pages, Duplicate Pages, Unsubmitted data points, Missing Labs, FIPRS and Segment promotion.• Running Tools like QPMT (Query Performance Management Tool) for QDR generation.• Running DET-MIF (Data Extraction Tool - Move It Forward) for SAS listings and copy forward of comments.• Preform DRT review, IPD reconciliation.• Pulling Cognos Reports, QCT Reports, DMP (Data Management Plan).• Hands on experience on EDC (Electronic data capture) Forecasting and Tracking and DMT (Data Management Tool).• Referring to Tier classification documents and eCRF specific instructions for data review.• Doing QC of samples of Queries and SAS listings.

Experience

1. Clinical Data Specialist

   Labcorp

   Jan 2023 — Present · Bengaluru, IN

Education

• Trident Academy of Creative Technology (TACT), Bhubaneswar

  Bachelor of Science, Biotechnology

• Trident Academy of Creative Technology (TACT), Bhubaneswar

  Bachelor of Biotechnology, Biotechnology

  2015 — 2018

• Sri Chaitanya

  12th

• Avigna clinical research institute (ACRI)

  Pg diploma in clinical research, clinical research

  2018 — 2018

• Avigna Clinical Research Institute

  Postgraduate Degree, Clinical Research

• DPS

  10th