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Clinical Data Associate I / Ii / Iii

2–5 years years
not specified
10 Sept. 5, 2025
Job Description
Job Type: Remote Education: Bachelor’s degree in life sciences, natural sciences, health sciences, or a related field. 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

Job Title:

Clinical Data Associate I / II / III

πŸ“ Location: Remote – India
πŸ†” Job ID: 25101259
πŸ“… Updated: August 21, 2025
🏒 Company: Syneos Health


🏒 About Syneos Health

Syneos Health® is a global, fully integrated biopharmaceutical solutions company, accelerating customer success through clinical, medical, and commercial expertise. With 29,000+ employees across 110 countries, Syneos Health partners with life sciences companies to bring therapies to market faster and smarter.

Over the past 5 years:

  • Partnered on 94% of FDA-approved novel drugs

  • Supported 95% of EMA-authorized products

  • Conducted 200+ studies across 73,000+ sites and 675,000+ trial patients

🌐 Learn more: www.syneoshealth.com


πŸ‘©‍πŸ’» Position Summary

The Clinical Data Associate (CDA) is responsible for performing and supporting clinical data management (CDM) activities across all study phases. This includes data cleaning, discrepancy management, database testing, documentation, and data reconciliation in both paper and electronic data capture (EDC) environments. The role level (I, II, III) will reflect experience and leadership responsibilities.


πŸ“Œ Key Responsibilities

πŸ“Š Clinical Data Management

  • Adhere to project contracts and scope of work, updating project management on progress.

  • Follow Clinical Data Management Plans (DMPs) and Data Validation Specifications (DVS).

  • Perform User Acceptance Testing (UAT) for CRFs, data entry screens, edit checks, SDV, and matrices.

  • Review discrepancy output and resolve queries according to protocol-defined rulings.

  • Enter, clean, and reconcile data from CRFs, labs, IRT, SAE, PK/PD, and external vendor sources.

πŸ§ͺ Database and Documentation

  • Review and document CRF/eCRF designs and visit structures.

  • Perform database QC checks, both paper-based and electronic.

  • Support and maintain Data Management Study File (DMSF) documentation.

  • Generate and manage reports (Discoverer, BOXI, J-Review).

  • Assist in designing edit checks and review DVS specs for accuracy.

πŸ”„ Data Reconciliation

  • Reconcile data with external sources including:

    • Labs

    • SAE reports

    • IVRS/IRT

    • PK/PD and eDiaries

🧠 Quality Control and Review

  • Conduct peer reviews and feedback for other CDAs.

  • Create and update CRF/eCRF Completion Guidelines and other SOP-compliant documentation.

  • Perform SAS mapping QC, track discrepancies, and maintain test logs.

  • Contribute to interim reviews, dry runs, and database lock/freeze procedures.

πŸ—‚οΈ Team Collaboration & Project Support

  • Serve as QC Coordinator for paper studies.

  • Provide training to CDAs on project-specific tools and processes.

  • Act as a backup Project Data Manager (PDM) when needed.

  • Participate in sponsor and team meetings, document minutes, and maintain action tracking.


βœ… Required Qualifications

πŸŽ“ Education

  • Bachelor’s degree in life sciences, natural sciences, health sciences, or a related field.

🧠 Experience

  • 2–5 years of experience in Clinical Data Management (CDM).

  • Experience with:

    • Inform EDC

    • Data discrepancy management

    • Vendor data reconciliation

    • SAE, PK/PD, IVRS, and lab data cleaning

    • Study conduct and closeout activities

  • Familiarity with CDISC standards and clinical trial documentation.

πŸ› οΈ Technical Skills

  • Strong knowledge of MS Office (Excel, Word, Outlook).

  • Comfortable with data management systems and tools (e.g., SAS, Inform).

  • Typing speed and accuracy are important.

  • Basic understanding of coding processes and terminology is helpful.

🌐 Soft Skills

  • Strong communication, presentation, and interpersonal skills.

  • Detail-oriented with strong organizational and time-management skills.

  • Capable of working both independently and collaboratively in cross-functional teams.

  • Adaptable to changing priorities and timelines.

🌍 Preferred Experience

  • Therapeutic areas: Vaccines, Oncology (preferred)

  • Experience in clinical trials, drug development, or related healthcare environments.

  • Familiarity with medical terminology.

  • Startup experience and metrics/CPT knowledge is a plus.


🌟 Why Join Syneos Health

  • Career development & progression

  • Diversity & inclusion driven “Total Self” culture

  • Work that matters globally

  • Supportive leadership and technical training

  • Opportunities to work on global clinical trials impacting millions of lives


πŸš€ Next Steps

πŸ”— Apply Now
πŸ“¬ Not ready yet? Join Our Talent Network


πŸ“ Additional Information

  • Role levels (I / II / III) may vary based on candidate experience.

  • Responsibilities may be adjusted based on business needs.

  • Compliance with applicable corporate, regulatory, and legal requirements is expected.

  • Travel requirement: Up to 25%, as needed


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