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Clinical Data Associate I/Ii

1-2 years
Not Disclosed
10 Nov. 12, 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

Clinical Data Associate I/II

Job ID:

25102916

Posted Date:

November 3, 2025

Location:

Nationwide, United States

Company:

Syneos Health® – Fully integrated biopharmaceutical solutions organization


🌟 Role Overview

The Clinical Data Associate (CDA) I/II supports all clinical data management (CDM) activities required for clinical trials. The role involves data entry, validation, quality review, reconciliation, and coordination while providing guidance to other CDAs. The CDA ensures accuracy, compliance, and timely processing of clinical trial data across different systems and study types (EDC and paper-based).


⚙️ Key Responsibilities

Clinical Data Management & Validation

  • Adhere to study-specific CDM plans and contract requirements.

  • Create and enter test data for User Acceptance Testing (UAT) and SDTM.

  • Perform UAT for data entry screens, edits, and review listings.

  • Receive and enter lab normal ranges.

  • Conduct discrepancy (edit check) reviews, validate data, and resolve queries per DVS/DMP.

  • Perform internal QC checks for paper and EDC studies.

  • Ensure all CRFs, DCFs, and electronic storage media comply with SOPs.

Data Reconciliation & Reporting

  • Ensure external datasets (lab, PK, IRT, electronic diaries) align with clinical database.

  • Run data cleaning and status reports.

  • Perform SAE reconciliations and maintain coding understanding.

  • Support interim, dry run, and data cut processes.

Team Support & Coordination

  • May coordinate and provide guidance to other CDAs.

  • Provide training on data management systems and processes.

  • Participate in internal/external meetings and audits.

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

Time & Task Management

  • Prioritize multiple tasks across projects.

  • Adapt to changes in timelines or priorities.

  • Communicate proactively regarding task completion and workload capacity.


🎓 Qualifications & Experience

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

  • 1–2 years of experience in clinical data management preferred.

  • Familiarity with CDM practices, EDC systems (Veeva, Oracle Clinical, Rave, or Inform).

  • Knowledge of clinical data, ICH/GCP, and medical terminology.

  • Proficient in MS Windows, Word, Excel, email; excellent keyboard accuracy.

  • Strong communication, organizational, and multitasking skills.

  • Ability to work independently or in a multi-disciplinary team.

  • Minimal travel may be required (up to 25%).


💼 Work Environment & Benefits

  • Opportunity to work on diverse clinical trials across therapeutic areas.

  • Participate in internal trainings (CDA Knowledge College) to maintain system proficiency.

  • Contribute to high-quality clinical trial data management.

Syneos Health is committed to diversity, inclusion, and equal employment opportunities.


📌 Summary

The Clinical Data Associate I/II ensures the accuracy, quality, and compliance of clinical trial data, performs validation and reconciliation tasks, and may guide junior CDAs. This role is integral to the success of clinical trials by supporting data management, audit readiness, and adherence to SOPs, GCP, and regulatory standards.