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Clinical Data Associate I / Ii

Precision For Medicine
Precision For Medicine
2+ years
Not Disclosed
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.