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.