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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-Hyderabad
Updated: September 10, 2025
Job ID: 25101587


Company Overview

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization that accelerates customer success by translating clinical, medical, and commercial insights into impactful outcomes.

  • Patient- and customer-centric Clinical Development model

  • Focus on process simplification and operational excellence

  • Collaborative teams innovating to deliver therapies efficiently

Global Footprint:

  • 29,000 employees across 110 countries

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

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

Learn more: www.syneoshealth.com


Why Syneos Health

  • Career Development: Mentorship, training, peer recognition, 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) leads collection and management of non-CRF data across multiple studies. The role includes study setup, conduct, and closeout activities, and may act as backup to the Project Data Manager (PDM) for global clinical trials.

Key Focus Areas:

  • Non-CRF data acquisition and vendor coordination

  • Study setup, validation, and data quality oversight

  • Mentorship and leadership of other CDAs


Core Responsibilities

Data Acquisition & Management

  • Lead collection and processing of non-CRF data (e.g., central labs, ECG, eCOA/ePRO, devices, sensors, IVRS/IWRS)

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

  • Enter lab normal ranges and complete CDMS access forms

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

  • Maintain QC for paper and EDC studies, including data reconciliation and review of DCFs/CRFs

  • Run data cleaning, status reports, and SAE reconciliations

  • Ensure consistency of external datasets with the clinical database

  • Post-migration testing on screens, edit checks, matrices, and role changes

Project & Study Oversight

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

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

  • Provide PDM backup support, including metrics reporting and project updates

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

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

Documentation & Compliance

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

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

  • Implement, maintain, and approve vendor transfer agreements and plans

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

Mentorship & Training

  • Train and mentor other CDA staff on project-specific requirements

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

  • Provide EDC training to 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 activities

  • 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

    • Proficiency in MS Office (Word, Excel, Email)

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

  • Soft Skills:

    • Strong communication, presentation, and interpersonal skills

    • Leadership, mentoring, and cross-functional collaboration

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

Additional Requirements:

  • Ability to lead all non-CRF activities independently

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

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


Additional Information

  • Tasks may be adjusted at the company’s discretion

  • Equivalent experience, skills, and education will be considered

  • Compliance with local employment legislation and ADA requirements


How to Apply

  • Apply directly through the Syneos Health careers portal

  • Join the Talent Network for future opportunities