Tejas P.
Junior Data Manager (Clinical Data Management)
Experience
Junior Data Manager (Clinical Data Management)
Tata Consultancy Services
- Executed comprehensive data validation processes and performed manual data review across multiple global projects
- Identified, generated, and resolved discrepancies through efficient query management aligning with the Data Validation Specification (DVS)
- Performed critical vendor data reconciliations, including SAE reconciliation, and addressed inconsistencies between the clinical database and external datasets (e.g., lab and PK/PD data)
- Supported study start-up by providing input into the DVS, coordinating and executing User Acceptance Testing (UAT) for data entry screens and edit checks, and ensuring full data dictionary quality control
- Coordinated the work of junior team members and provided project-specific training and mentorship on data management activities and standard operating procedures
- Supported audit readiness by systematically reviewing study files, documentation, and data listings to ensure compliance with ICH-GCP and internal SOPs
- Utilized Medidata Rave and Oracle Clinical to run data cleaning and status reports, minimizing rework by adhering to study instructions and anticipating the effects of changes on data quality
Summary
Highly competent and results-driven Clinical Data Management (CDM) professional with 2+ years of experience successfully managing complex, global clinical trials. Expertise includes the full lifecycle of data management, from study start-up (UAT, DVS input) through conduct (Discrepancy Management, Vendor Reconciliation, Data Cleaning) and closeout (SAE Reconciliation, data delivery). Proven ability to coordinate tasks, provide training, and ensure ICH-GCP compliance using industry-standard EDC systems like Medidata Rave and Inform EDC, Oracle Clinical. Seeking a challenging Clinical Data Associate role to lead and execute high-quality data deliverables.
Skills
Clinical Data Management: Discrepancy Management, Data Validation, Vendor Reconciliation (Lab, Pk, Pd, Ivrs), Sae Reconciliation, Data Cleaning, Manual Data Review, Study Closeout, Cpt, Study Status Report
Study Setup & Qc: User Acceptance Testing (Uat), Data Validation Specification (Dvs) Input, Qc Of Data Dictionary, Post-migration Testing
Systems & Tools: Medidata Rave, Ms Excel, Clinical Database Systems, Inform Edc (Conceptual/procedural Experience)
Compliance & Operations: Ich-gcp, Regulatory Compliance, Audit Readiness, Data Management Plan (Dmp), Training And Mentorship, Organizational Skills
Therapeutic Areas (Preferred): Vaccine & Oncology (Conceptual Experience)
Languages
Education
Dr. Rajendra Gode College of Pharmacy
Bachelor of Pharmacy · Pharmacy · Malkapur, India
Certifications & licenses
Clinical Research Fundamentals
TCS
ICH-GCP Certification (Good Clinical Practice)
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