Job Title:
Clinical Data Associate I / II / III
📍 Location: Remote – India
🆔 Job ID: 25101259
📅 Updated: August 21, 2025
🏢 Company: Syneos Health
🏢 About Syneos Health
Syneos Health® is a global, fully integrated biopharmaceutical solutions company, accelerating customer success through clinical, medical, and commercial expertise. With 29,000+ employees across 110 countries, Syneos Health partners with life sciences companies to bring therapies to market faster and smarter.
Over the past 5 years:
Partnered on 94% of FDA-approved novel drugs
Supported 95% of EMA-authorized products
Conducted 200+ studies across 73,000+ sites and 675,000+ trial patients
🌐 Learn more: www.syneoshealth.com
👩💻 Position Summary
The Clinical Data Associate (CDA) is responsible for performing and supporting clinical data management (CDM) activities across all study phases. This includes data cleaning, discrepancy management, database testing, documentation, and data reconciliation in both paper and electronic data capture (EDC) environments. The role level (I, II, III) will reflect experience and leadership responsibilities.
📌 Key Responsibilities
📊 Clinical Data Management
Adhere to project contracts and scope of work, updating project management on progress.
Follow Clinical Data Management Plans (DMPs) and Data Validation Specifications (DVS).
Perform User Acceptance Testing (UAT) for CRFs, data entry screens, edit checks, SDV, and matrices.
Review discrepancy output and resolve queries according to protocol-defined rulings.
Enter, clean, and reconcile data from CRFs, labs, IRT, SAE, PK/PD, and external vendor sources.
🧪 Database and Documentation
Review and document CRF/eCRF designs and visit structures.
Perform database QC checks, both paper-based and electronic.
Support and maintain Data Management Study File (DMSF) documentation.
Generate and manage reports (Discoverer, BOXI, J-Review).
Assist in designing edit checks and review DVS specs for accuracy.
🔄 Data Reconciliation
Reconcile data with external sources including:
Labs
SAE reports
IVRS/IRT
PK/PD and eDiaries
🧠 Quality Control and Review
Conduct peer reviews and feedback for other CDAs.
Create and update CRF/eCRF Completion Guidelines and other SOP-compliant documentation.
Perform SAS mapping QC, track discrepancies, and maintain test logs.
Contribute to interim reviews, dry runs, and database lock/freeze procedures.
🗂️ Team Collaboration & Project Support
Serve as QC Coordinator for paper studies.
Provide training to CDAs on project-specific tools and processes.
Act as a backup Project Data Manager (PDM) when needed.
Participate in sponsor and team meetings, document minutes, and maintain action tracking.
✅ Required Qualifications
🎓 Education
Bachelor’s degree in life sciences, natural sciences, health sciences, or a related field.
🧠 Experience
2–5 years of experience in Clinical Data Management (CDM).
Experience with:
Inform EDC
Data discrepancy management
Vendor data reconciliation
SAE, PK/PD, IVRS, and lab data cleaning
Study conduct and closeout activities
Familiarity with CDISC standards and clinical trial documentation.
🛠️ Technical Skills
Strong knowledge of MS Office (Excel, Word, Outlook).
Comfortable with data management systems and tools (e.g., SAS, Inform).
Typing speed and accuracy are important.
Basic understanding of coding processes and terminology is helpful.
🌐 Soft Skills
Strong communication, presentation, and interpersonal skills.
Detail-oriented with strong organizational and time-management skills.
Capable of working both independently and collaboratively in cross-functional teams.
Adaptable to changing priorities and timelines.
🌍 Preferred Experience
Therapeutic areas: Vaccines, Oncology (preferred)
Experience in clinical trials, drug development, or related healthcare environments.
Familiarity with medical terminology.
Startup experience and metrics/CPT knowledge is a plus.
🌟 Why Join Syneos Health
Career development & progression
Diversity & inclusion driven “Total Self” culture
Work that matters globally
Supportive leadership and technical training
Opportunities to work on global clinical trials impacting millions of lives
🚀 Next Steps
🔗 Apply Now
📬 Not ready yet? Join Our Talent Network
📝 Additional Information
Role levels (I / II / III) may vary based on candidate experience.
Responsibilities may be adjusted based on business needs.
Compliance with applicable corporate, regulatory, and legal requirements is expected.
Travel requirement: Up to 25%, as needed
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