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Sr Cda (Data Acquisition Specialist-Non-Crf)

5-7 years
Not Disclosed
10 Sept. 17, 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

Senior Clinical Data Associate (CDA) – Data Acquisition Specialist (Non-CRF)

Location: IND-Remote
Updated: September 10, 2025
Job ID: 25101587


Company Overview

Syneos Health® is a fully integrated biopharmaceutical solutions organization focused on accelerating customer success by translating clinical, medical, and commercial insights into outcomes.

  • Patient- and customer-centric Clinical Development model

  • Focus on simplifying processes and operational efficiency

  • Collaborative, innovative teams delivering therapies worldwide

Global Footprint:

  • 29,000 employees across 110 countries

  • 94% of novel FDA-approved drugs and 95% of EMA-authorized products supported in the last 5 years

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

Learn more: www.syneoshealth.com


Why Syneos Health

  • Career Development: Mentorship, technical training, and advancement opportunities

  • Inclusive Culture: Total Self culture enabling authenticity, diversity, and belonging

  • Collaborative Environment: Cross-functional teamwork fostering innovation


Role Summary

The Sr CDA – Data Acquisition Specialist (Non-CRF) is responsible for leading the collection and management of non-CRF data across multiple studies, including study setup, conduct, and closeout activities. This role may also serve as a backup to the Project Data Manager (PDM).

Key Responsibilities:

  • Lead non-CRF data acquisition and vendor management

  • Oversee study setup, validation, and data quality

  • Mentor and supervise other CDAs

  • Act as point-of-contact (POC) for cross-functional communication


Core Responsibilities

Data Acquisition & Management

  • Collect, process, and deliver non-CRF test and production data (e.g., lab, ECG, eCOA/ePRO, devices, IVRS/IWRS)

  • Perform User Acceptance Testing (UAT) for screens, edit checks, SDV configuration, and matrices

  • Enter lab normal ranges and CDMS access forms

  • Resolve discrepancies, queries, and apply self-evident corrections per DMP/DVS

  • Conduct QC for paper and EDC studies; reconcile CRFs and DCFs

  • Run data cleaning, status reports, SAE reconciliations

  • Ensure external datasets align with clinical database

Project Oversight & Coordination

  • Maintain awareness of project scope; communicate updates to PM/BPM

  • Attend meetings, in-process reviews, audits, and sponsor interactions

  • Provide PDM backup support (metrics reporting, project updates)

  • Lead cross-functional non-CRF activities and vendor collaborations

  • Create ad-hoc reports, Discoverer/BOXI/J-Review reports, and update DVS

Documentation & Compliance

  • Review database design, CRF/eCRF structure, and DMSF

  • Provide input on Data Validation Specifications (DVS) and edit checks

  • Implement, maintain, and approve vendor transfer agreements

  • Ensure compliance with SOPs, WIs, ICH/GCP, and corporate policies

Mentorship & Training

  • Train and mentor CDA staff on project-specific requirements

  • Serve as SME for platform/process-specific tasks and non-CRF data

  • Conduct EDC training for internal and external team members


Qualifications & Experience

  • Education: BA/BS in biological sciences or related health/science discipline

  • Experience: 5–7 years in Clinical Data Management, including external vendor and non-CRF setup

  • Technical Skills:

    • Central lab, ECG, eCOA/ePRO, device/sensor testing, IWRS/IVRS

    • Data transfer agreements, study setup, data validation

    • DM systems: Oracle Clinical, Rave, Inform; relational databases preferred

    • MS Office proficiency (Word, Excel, Email)

  • Regulatory Knowledge: ICH/GCP, clinical trial processes, medical terminology

  • Soft Skills:

    • Excellent communication, presentation, and interpersonal skills

    • Leadership, mentoring, and cross-functional collaboration

    • Time management, multitasking, flexibility, and attention to detail

Additional Requirements:

  • Lead all non-CRF activities independently

  • Act as non-CRF POC for customer/vendor collaboration

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


Additional Information

  • Tasks and responsibilities may be adjusted at the company’s discretion

  • Equivalent experience, skills, and education considered

  • Compliance with local employment legislation and ADA requirements


How to Apply

  • Apply via the Syneos Health careers portal

  • Join the Talent Network for future opportunities