Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

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