Key Accountabilities-Perform data review and query management across clinical trial data, working with study team members and CRO partners to drive queries to resolution.-Perform detailed review of eCOA and external data per the Data Review Plan — acting as liaison with eCOA and external data vendors, QCing a sample of vendor-processed data clarification requests, and maintaining the centralised study data issues log.-Perform reconciliation of eCOA and external data against EDC data, and SAE reconciliation with the safety team, resolving discrepancies with the applicable parties.-Contribute to the creation and maintenance of study data cleaning plan components — edit checks (data validation plan), listing review checks, data integration and transfer specifications, external data reconciliation plans, coding guidelines, SAE reconciliation guidelines and database lock plans — and perform additional review activities for interim and final database locks.-Support set-up and testing of EDC, IRT, eCOA and ePRO tools; contribute to eCRF Completion Guidelines and associated documentation, and assist with account access and training materials.-Maintain study documentation in the eTMF and department project files, perform periodic quality reviews, take meeting minutes, and complete data archival activities.-Prepare and distribute performance metrics to stakeholders, escalate to the CDM Lead as needed,



and support inspection readiness and internal and regulatory inspections.-Coordinate, oversee and mentor other data coordinators, and assist with quality review of activities performed by the CRO.Experience-8 years of relevant experience preferred in data management or drug development within a GCP and clinical research regulatory environment, or an equivalent combination of training and experience.-Working understanding of clinical trial documents — protocols, case report forms, data management plans, study reports — and the processes around them.-Hands-on experience with electronic data collection systems, and a track record of managing multiple deliverables against competing deadlines.-Knowledge of data management best practices and technologies, and of FDA and ICH regulations and industry standards applicable to data capture and data management.Skills and Competencies-Solid attention to detail, with good organisational and time management skills.-Demonstrated communication and project management skills, effective across sponsor, CRO and vendor teams.-Quick learner, comfortable adopting new technologies and systems; advanced knowledge of Microsoft Office.-Comfortable with ambiguity, with strong teamwork, interpersonal, conflict resolution and problem-solving skills.

📌 Clinical Data Manager (Bengaluru)
🏢 Weltrix Biometrics CRO
📍 Bengaluru