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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