Job Title:
Clinical Data Associate II
Location:
Bangalore, Karnataka, India
Chennai, Tamil Nadu, India
Job Type:
Regular – Full-Time
Division:
Precision for Medicine – Clinical Solutions
Requisition Number:
5545
Position Summary:
The Clinical Data Associate II supports data management activities for clinical trials from initiation through database lock. Responsibilities include database setup, data entry, UAT testing, query management, coding, and coordination with internal and external teams. This role involves collaboration with Lead Data Managers, sponsors, vendors, and study teams to ensure the integrity and quality of clinical trial data.
Key Responsibilities:
Serve as backup or team member to the Lead DM, ensuring timely task execution.
Support database builds and conduct UAT with required documentation.
Develop CRF specifications and edit check requirements.
Perform and QC data entry for paper-CRF studies as needed.
Review and query clinical trial data per the Data Management Plan.
Perform coding (e.g., MedDRA, WHODrug) to ensure consistency and accuracy.
Assist in SAE/AE reconciliation and vendor data coordination.
Run patient and study-level reports and metrics.
Collaborate with sponsors, vendors, and internal teams on project deliverables.
Train clinical staff on CRFs, EDC systems, and study-specific items.
Support audits, issue resolution, and document control.
May contribute to SAS programming, SOPs, and CSRs.
May present at meetings and training sessions.
Qualifications:
Minimum Required:
Bachelor's degree or equivalent experience.
2+ years of experience in clinical data management.
Other Required:
Strong knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook).
Excellent organizational, communication, and interpersonal skills.
Professional proficiency in English (written and verbal).
Preferred:
Background in clinical, scientific, or healthcare disciplines.
Additional Notes:
Some travel may be required.
Be vigilant about job scams; Precision for Medicine only offers positions following official communication and interviews.
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