Clinical Data Management

RESPONSIBILITIES Lead data management planning, CRF design, and database setup Act as clinical data point of contact for assigned clinical studies for internal and external stakeholders Lead clinical data management aspects of processing radiological images received for client projects in accordance with standard operating procedures Lead CDM Tasks & Process in accordance with SOPs’ & Internal QMS Process. Author the study documentation of the trial related CDM documents (DMP, eCCG, DTA etc…) Lead the set-up, conduct and Lock phases of the trial Mentor , Train team members with less experience in gaining knowledge and learning process. As required understand new EDC Tools and deliver performance in suitable applicable time. Follow the internal Quality process for delivering milestones with quality Understand the annotations of eCRFs, data linkage between the process and stakeholders, coordinate with all stakeholders. Perform Query management, Offline listings review, external reconciliation and other DM tasks as and when required. Contribute to RBQM Process , support data analytics team for generation of required standard metrics. Review, understand and apply the regulatory standards (CDASH, SDTM ). Perform UAT, Validation & Migrations as required. Perform other DM Tasks as required, Education and experience Bachelor’s degree or equivalent combination of education and relevant professional experience is required. Minimum Five years’ hands-on clinical data management experience in clinical trials is required. Experience with database design and implementation, particularly EDC systems and eCRF design, is expected. Working knowledge of Good Clinical Practice (GCP) guidelines is required. Advanced proficiency with Microsoft Office and preferably some AI knowledge.