Instagram
youtube
Facebook

Senior Clinical Data Associate (External Data Associate)

5+ years
Not Disclosed
10 Oct. 4, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences 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

🧑‍💼 Position Title:

Senior Clinical Data Associate (External Data Associate)


🌍 Location:

IND-Remote


🆔 Job ID:

25101749


🎯 Job Overview:

Responsible for leading Clinical Data Associates (CDAs) in data management activities for global clinical trials. Supports data integrity, UAT, external vendor data integration, and may serve as a backup for the Project Data Manager (PDM). Ensures timely, accurate, and compliant data handling in line with protocols, SOPs, and project requirements.


🌟 Core Responsibilities:

🔹 Data Management & Integration

  • Collaborate with DM and DMQL to discuss vendor/data types using Veeva vendor tracker.

  • Create DTS and DTA based on vendor tracker using P21 standards.

  • Generate DS requests for missing standards.

  • Perform import review for test and production transfers during milestones.

  • Apply changes based on protocol amendments.

  • Conduct eCOA device UAT and create UAT test scripts.

  • Perform key mappings and unblinding rules as required.

  • Adhere to Good Documentation Practices (GDP) and follow ETMF review/approval process.

🔹 Database & System Activities

  • Create and enter test data for UAT.

  • Review discrepancy (edit check) outputs and validation listings; resolve queries and re-queries.

  • Internal QC checks for paper studies; oversee CRFs and DCFs documentation.

  • Conduct DM quality review for EDC studies.

  • Review lab normal ranges and data import/export forms.

  • Perform SAS mapping QC and post-migration testing.

  • Run data cleaning and status reports; perform SAE reconciliations.

  • Ensure external datasets (lab, eCOA, PK, IRT) are consistent with clinical database.

  • Review database design specifications, annotated CRFs, and eCRF visit structures.

  • Provide input to Data Validation Specification (DVS), including edit checks and validated listings.

🔹 Leadership & Mentorship

  • Train, mentor, and provide feedback to less experienced CDAs and project team members.

  • Serve as platform or process-specific Subject Matter Expert (SME).

  • May act as backup for PDM and represent the department in internal/external meetings.

  • Lead internal meetings and participate in audits or inspections.

🔹 Documentation & Reporting

  • Maintain study-specific documents (DMP, CRF/eCRF Completion Guidelines, import/export agreements).

  • File documentation in Data Management Study File (DMSF).

  • Create ad-hoc data cleaning reports and project metrics reports.

  • Ensure compliance with study-specific processes and timelines.


🎓 Qualifications & Requirements:

  • BA/BS degree in biological sciences or related natural science/healthcare field.

  • 5+ years of experience in external data handling.

  • Client-facing experience required.

  • Experience with eCOA/ePRO and UAT testing.

  • Proficiency with MS Windows, Word, Excel, and email applications; strong keyboard skills.

  • Familiarity with clinical research, drug development, or data management processes.

  • Knowledge of medical terminology.

  • Excellent written and verbal communication, presentation, and interpersonal skills.

  • Strong organizational, planning, time management, and multitasking abilities.

  • Leadership and mentoring skills; ability to work independently and within a team.

  • Minimal travel required (up to 25%).


🌐 Why Syneos Health:

  • Inclusive Total Self culture promoting diversity, belonging, and professional growth.

  • Work with global teams across 29,000 employees in 110 countries.

  • Opportunity to impact FDA-approved and EMA-authorized drug studies.


📌 Summary:

The Senior Clinical Data Associate leads CDAs in clinical data management, ensuring high-quality data handling, UAT, vendor data integration, and compliance with study protocols. Supports PDM as needed, provides mentorship, and contributes to process improvements and documentation management for global clinical trials.