Vikas Saini
Clinical Data Associate II 2.5+ years of experience_CDM.
- Role
- Clinical Data Associate Ii at Precision For Medicine
- Location
- New Delhi, DL, IN
- LinkedIn followers
- 500 followers
About Vikas Saini
knowledge and understanding of clinical trials, consenting procedure and forms, knowledge…
Experience
Clinical Data Associate Ii
Aug 2025 — Present · Pune, IN
Support the Lead DM as a back-up and/or team member, ensuring continuity, responsiveness, and that tasks are performed in a timely manner• May perform data entry for paper-CRF studies, as needed• May perform quality control of data entry• May develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders• May assist in building clinical databases• Conduct database build UAT and maintain quality controlled database build documentation• Assist in specifying requirements for all edit check types e.g. electronic, manual data review, edit checks, etc.• Responsible for creating, revising, appropriate versioning and maintaining data management documentation.• Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed• Review and query clinical trial data according to the Data Management Plan• Assist in line listing data review based on the guidance provided by the sponsor and/or Lead DM• Run patient and study level status and metric reporting• Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency• Assist with coordinating SAE/AE reconciliation• Assist with liaising with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables• May assist with SAS programming and quality control of SAS programs used in the Data Management department• May assist in identifying and troubleshooting operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders• May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project
Education
Uttrakhand Technical University, Dehradun
Bachelor of Pharmacy - BPharm
NIDA clinical trials network
Certificate
NATIONAL INSTITUTE OF ELECTRONICS & INFORMATION TECHNOLOGY (NIELIT)
Course on Computer Concepts
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