Senior Clinical Data Associate (External Data Associate)

Syneos Health

5+ years

Not Disclosed

Remote

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.

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Senior Clinical Data Associate (External Data Associate)

Job Description

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