Clinical Data Associate I / Ii

2+ years

Not Disclosed

Bangalore

10 March 3, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Data Associate I / II

Location: Bangalore, Karnataka, India · Chennai, Tamil Nadu, India
Job Type: Full-time

Position Summary:
The Clinical Data Associate II provides data management support for clinical trial processes from study startup to post-database lock under direct supervision. Responsibilities adhere to SOPs, regulatory directives, and study-specific guidelines. This role may also involve database development, testing, and data management activities.

Essential Responsibilities:

Support the Lead Data Manager as a backup or team member, ensuring task continuity and timely execution.
Perform data entry for paper-CRF studies as needed.
Conduct quality control checks for data entry.
Develop CRF specifications from clinical study protocols and coordinate stakeholder review.
Assist in clinical database development and conduct database build UAT.
Specify requirements for edit checks (electronic, manual data review, etc.).
Maintain accurate versioning of data management documentation.
Train clinical research personnel on CRF, EDC, and project-related procedures.
Review and query clinical trial data per the Data Management Plan.
Assist in line listing data review per sponsor and Lead DM guidance.
Generate patient and study-level status and metric reports.
Perform medical coding to ensure logic and consistency.
Assist in SAE/AE reconciliation coordination.
Liaise with third-party vendors for data-related deliverables.
May assist with SAS programming and quality control of SAS programs.
Identify and troubleshoot study-related operational issues based on audit reports and team input.
Review and provide feedback on protocols, SAPs, and CSRs when required.
Contribute to developing and maintaining SOPs for data and database management.
Communicate with study sponsors, vendors, and project teams regarding database-related issues.
Conduct software demonstrations, training sessions, and project presentations.
May require travel.
Perform other assigned duties.

Qualifications:

Minimum Requirements:

Bachelor's degree or a combination of related experience.
2+ years’ experience in clinical data management.
Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
Strong organizational and communication skills.
Professional English proficiency (written and oral).

Preferred:

Experience in a clinical, scientific, or healthcare discipline.

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Clinical Data Associate I / Ii

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