Clinical Data Management Specialist

Job Overview

We are looking for a Clinical Data Management (CDM) Executive with experience in database design, CRF/eCRF development in EDC Systems for Clinical Trials. He/She should be aware about regulatory-compliant data handling. This position will be dedicated to working for our client, supporting their database design and data management needs in our EDC System.

Experience

1-2 Years in Clinical Data Management/Clinical Data Associate roles with hands-on experience in data management EDC/ CDMS software/tools.

Responsibilities and Duties

·        Collaborate with client study teams to create user-friendly CRFs/eCRFs in EDC/ CDM System.

·        Design and configure study databases in data management tools, including visit schedules, forms, fields, and relational structures.

·        Prepare/Review the validation logic, edit checks, and system rules to ensure data quality as per Protocol/ DVP.

·        Perform structured User Acceptance Testing (UAT) for databases, forms, and edit checks and log, track, and retest issues until resolved.

·        Participate in functional and user acceptance testing of our in-house EDC system.

·        Validate edit checks, workflows, and data integrity in the EDC tool.

·        Participate in functional and user acceptance testing of our in-house EDC system.

·        Create and execute test cases to verify compliance with system requirements and regulatory guidelines.

Qualifications

·        Bachelor’s/Master’s degree in Life Sciences, Pharmacy, Physiotherapy, or related discipline.

·        Good written and verbal communication abilities.

·        Experience in clinical database design and data management using data management tools.

·        Understanding of CRF/eCRF design, DMP/DVP preparation, edit check specifications, and UAT processes.

·        Experience in query management and database lock activities.

·        Strong analytical, documentation, and problem-solving skills.