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Sr Cda (Data Acquisition Specialist-Non-Crf)

5-7 years
Not Disclosed
10 Sept. 19, 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

Job Title: Sr CDA (Data Acquisition Specialist – Non-CRF)

  • Updated: September 10, 2025

  • Location: IND – Remote

  • Job ID: 25101587


About Syneos Health

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We combine clinical, medical affairs, and commercial insights to deliver better outcomes in modern healthcare.

  • Global Presence: 29,000 employees across 110 countries.

  • Impact: Partnered on 94% of all Novel FDA-approved drugs, 95% of EMA-authorized products, and 200+ studies across 73,000 sites and 675,000+ trial patients.

  • Culture: Committed to career growth, supportive leadership, technical training, recognition programs, and our Total Self culture that celebrates diversity, inclusion, and authenticity.

Motto: Work Here Matters Everywhere.


Job Summary

The Sr CDA (Data Acquisition Specialist – Non-CRF) leads Clinical Data Associates (CDAs) in collecting and managing Non-CRF data across multiple studies. Responsibilities span study set-up, conduct, and closeout. This role also supports and may act as a backup Project Data Manager (PDM) for global clinical trials.


Core Responsibilities

Study Setup & Data Management

  • Review and adhere to study-specific Data Management Plan (DMP).

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

  • Perform UAT for data entry screens, edits, data review listings, and Targeted Source Data Verification (SDV).

  • Review database design specifications and CRF/eCRF visit structures.

  • Ensure lab normal ranges and vendor data are properly entered and reconciled.

Data Quality & Validation

  • Conduct discrepancy checks, validation listing reviews, and apply corrections/queries per DMP.

  • Perform QC checks for both paper and EDC studies.

  • Reconcile Serious Adverse Events (SAEs).

  • Perform SAS mapping QC and ad-hoc data cleaning reports.

  • Run data cleaning/status reports and support interim/dry run data cuts.

Documentation & Reporting

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

  • Create/update study-specific documents (e.g., CRF/eCRF DMP, completion guidelines, data transfer agreements).

  • Complete Data Transfer Request Forms for sponsor/vendor.

  • Generate Discoverer, BOXI, and J-Review reports.

Leadership & Oversight

  • Mentor/train CDAs and review their work.

  • Act as Subject Matter Expert (SME) for non-CRF processes/platforms.

  • Lead non-CRF activities and serve as the primary point of contact (POC) for customers and vendors.

  • Support Project Data Manager with metrics, sponsor updates, and cross-functional collaboration.

Stakeholder & Audit Support

  • Liaise with Clinical Programming, Biostatistics, and Clinical Operations.

  • Participate in internal/external audits, inspections, and customer meetings.

  • Provide EDC training for internal/external teams.

  • Represent department in business development meetings when needed.


Qualifications

Education

  • BA/BS in biological sciences, natural sciences, or healthcare-related field.

Experience

  • 5–7 years in Clinical Data Management.

  • Strong experience in:

    • Non-CRF setup & external vendor data management.

    • Central labs, eCOA, ePRO, patient diaries, device/sensor testing.

    • Data transfer agreements, ECG, IWRS/IVRS testing, study startup & setup.

  • Familiarity with Oracle Clinical, Rave, Inform preferred.

  • Knowledge of ICH-GCP and medical terminology.

Technical Skills

  • Strong proficiency in MS Word, Excel, Windows, and email applications.

  • Relational database management software experience preferred.

  • Excellent keyboard speed and accuracy.

Soft Skills

  • Strong communication, presentation, and interpersonal skills.

  • Ability to influence, persuade, and build stakeholder trust.

  • Organizational and time-management skills with multitasking ability.

  • Adaptability under tight deadlines.

  • Proven leadership/mentoring capabilities.

Other

  • Compliance with corporate SOPs and business practices.

  • Willingness to travel up to 25%.


Summary

  • Focus: Non-CRF setup & data collection.

  • Scope: Leads activities across study setup, conduct, and closeout.

  • Impact: Ensures high-quality data delivery, vendor collaboration, and regulatory compliance for global clinical trials.


How to Apply

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