Manager 2-Clinical Data Management

The Manager 2-Clinical Data Management at Sun Pharmaceutical Industries Ltd in Gurgaon - R&D 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. The incumbent will be managing all data management aspects of assigned project(s) from setup to lock, attending regular meetings with the project team to discuss data management issues, and providing status updates. Reporting on quality and performance metrics, including timelines, to project leads and other stakeholders is also a key responsibility. Participation in in-house and external training courses when required, preparation/review of Data Management process control documents such as Data Management Plan, Data Edit Checks Specification, User Acceptance Testing, Data Transfer Agreements/Specifications, Reconciliation plans, CRF Completion Guidelines, and Coding Guidelines is expected. Additionally, coordinating and managing 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. Reviewing, freezing, and/or locking data in accordance with Data Management documents for accuracy, completeness, consistency, and validity, generating queries as necessary, coordinating with Medical Data Reviewer and/or Medical Monitor for the coding of medical terminology, and maintaining Data Management study documentation in an audit-ready status are essential duties. Reconciliation, including SAS/AE, Electronic Data Files (EDF), and third-party data against the clinical database, and tracking issues to resolution is also part of the role. The Manager 2-Clinical Data Management may present at investigator meetings and PM/CRA training sessions, as well as identify and recommend process improvements to the management team. The geographic scope for this position is global, and it is a full-time role with infrequent travel requirements. The ideal candidate should preferably have a minimum of a Bachelor's degree in a Life Science, Nursing, Computer Science, or related discipline, along with a minimum of 6 years of clinical data management experience including working knowledge using clinical data capture tools. Experience of leading global clinical studies is preferred.,