Sr. Executive / Executive - Clinical Data Management

Job description

**Title:** **Sr. Executive / Executive - Clinical Data Management** =================================================================== Date: Jul 27, 2026 Location: Gurgaon - R\&D Company: Sun Pharmaceutical Industries Ltd **Job Purpose** * The incumbent is responsible for effectively participating in the start-up and completion of multiple Data Management projects according to stakeholder requirements and in accordance to SOPs and other applicable standards in compliance with Sun Procedural Documents, ICH-GCP and local regulations **Key Roles and Responsibilities** * Effective management of all data management aspects of assigned project(s) from setup to lock. * Attend regular meetings with project team, for discussions relating to data management issues and provides status updates for the project. * Report on quality and performance metrics, including timelines, to project leads and other stakeholders * Participate in in-house and external training courses, where required. * Participate in the preparation/review of Data Management process control documents, including but not limited to Data Management Plan, Data Edit Checks Specification, User Acceptance Testing, Data Transfer Agreements/Specifications, Reconciliation plans, CRF Completion Guidelines, Coding Guidelines, etc. * Coordinate and manage training and EDC access for investigators, coordinators, data entry and CRAs on selected applications for data entry, cleaning, and running reports, as applicable to study parameters. * Review, freeze and/or lock data in accordance with Data Management documents for accuracy, completeness, consistency and validity, generate queries, as necessary, for sites and/or project team. * Coordinate with Medical Data Reviewer and/or Medical Monitor for the coding of medical terminology, as required. * Maintain Data Management study documentation in an 'audit-ready' status, * Perform reconciliation, including but not limited to SAS/AE, Electronic Data Files (EDF) and third-party data such as central labs and IVR, against the clinical database and track issues to resolution. * May present at investigator meetings and PM/CRA training sessions. * Identifies and recommends process improvements to management team, as identified. * May work independently as a CDMPL on assigned projects. **Qualification, Skill and Competencies Requirements** * Preferably a minimum of a Bachelor's degree in a Life Science, Nursing, Computer Science or related discipline. * Minimum 3 years of clinical data management experience including working knowledge using clinical data capture tool. * Experience with independently leading lobal clinical studies is preferred.