Senior Clinical Data Associate (Data Acquisition Specialist – Non-CRF)
📍 Location: Hyderabad, India
🆔 Job ID: 25101587
📅 Updated: September 10, 2025
About Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions company dedicated to accelerating customer success.
Global Workforce: 29,000 employees across 110 countries
Proven Impact: Partnered in 94% of FDA-approved novel drugs and 95% of EMA-authorized products in the last 5 years
Reach: Supported 200+ studies across 73,000 sites and 675,000+ trial patients
💡 Work Here Matters Everywhere
We foster career growth, technical and therapeutic training, peer recognition, and a Total Self Culture where employees are empowered to be authentic and inclusive.
Job Summary
The Sr CDA (Non-CRF) leads non-CRF data setup, acquisition, and management during study setup, conduct, and closeout for multiple clinical trials. The role also provides support to Project Data Managers (PDMs) and may serve as their backup.
Core Responsibilities
Study Setup & Database Activities
Review and adhere to study-specific Data Management Plans (DMPs).
Conduct User Acceptance Testing (UAT) for EDC screens, edit checks, and SDV configuration.
Design/review CRFs/eCRFs and database specifications.
Implement and approve non-CRF vendor transfer agreements/plans.
Set up IXRS/IRT systems and participate in system migrations.
Data Management & Quality Control
Receive, process, and deliver non-CRF datasets (central lab, eCOA, ePRO, sensors, ECG, diaries, IVRS/IWRS, PK data).
Perform discrepancy reviews, query management, and SAE reconciliation.
Run data cleaning/status reports and generate ad-hoc data cleaning outputs.
Ensure consistency of vendor data with clinical database records.
Maintain QC of study documentation and DMSF throughout the study lifecycle.
Collaboration & Leadership
Act as Non-CRF Point of Contact (POC) for sponsors and cross-functional teams.
Lead internal and external meetings, including customer/vendor discussions.
Train and mentor junior CDAs; provide feedback and oversight.
Support and occasionally back up PDMs in study management, metrics reporting, and sponsor updates.
Compliance & Documentation
Participate in internal/external audits and inspections.
Maintain inspection-ready documentation aligned with SOPs, ICH, and GCP.
Create/maintain key study documents: DMPs, completion guidelines, import/export agreements, data transfer forms.
Qualifications
Education
Bachelor’s degree in Biological Sciences, Natural Sciences, Health Care, or related field.
Experience
5–7 years in Clinical Data Management.
Strong expertise in non-CRF data setup and external vendor data management.
Hands-on experience with central lab, eCOA, ePRO, diaries, devices, ECG, IVRS/IWRS setup.
Familiarity with relational databases and Data Management systems (Oracle Clinical, Rave, Inform preferred).
Skills
Strong knowledge of ICH/GCP and clinical trial processes.
Proficiency in MS Word, Excel, Windows, and email applications.
Excellent written, verbal, and presentation skills.
Strong organizational, multitasking, and time management abilities.
Proven leadership and mentoring skills.
Additional Information
Minimal travel required (up to 25%).
Responsibilities may evolve based on business needs.
Equivalent education/experience will be considered.
Syneos Health promotes diversity, inclusion, and transferable skills—candidates are encouraged to apply even if not meeting every requirement.
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