- 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 current 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.
📌 Clinical Data Management (India)
🏢 SRM Technologies
📍 India
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