Job Title: Sr CDA (Data Acquisition Specialist-Non-CRF)
Updated: September 10, 2025
Location: IND – Pune
Job ID: 25101587
About Syneos Health
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. With 29,000 employees across 110 countries, we focus on innovation, collaboration, and patient-centered clinical development.
Work Here Matters Everywhere – We foster career growth, supportive leadership, technical and therapeutic training, and a diverse, inclusive culture where everyone belongs.
Job Summary
The Sr CDA (Data Acquisition Specialist – Non-CRF) is responsible for leading Clinical Data Associates in the collection, management, and oversight of non-CRF data during study setup, conduct, and closeout for multiple studies. The role may also act as a backup for the Project Data Manager (PDM) and ensures accuracy, compliance, and smooth delivery of non-CRF data management activities.
Core Responsibilities
Study Setup & Data Management
Lead and oversee non-CRF data setup and acquisition activities across multiple studies.
Review study-specific Data Management Plans (DMP) and update as required.
Create and test User Acceptance Testing (UAT) scenarios for EDC systems, edit checks, and Targeted Source Data Verification (SDV).
Review CRF/eCRF design, visit structure, and database specifications.
Implement and approve Non-CRF Vendor Transfer Agreements/plans/specifications.
Conduct post-migration testing and database validation activities.
Data Processing & Quality Control
Receive, process, and deliver non-CRF test and production data (eCOA, ePRO, device/sensor, ECG, central lab, IWRS/IVRS).
Perform data discrepancy checks, self-evident corrections, query management, and Serious Adverse Event (SAE) reconciliation.
Run data cleaning/status reports and generate ad-hoc data reports.
Ensure external vendor datasets (lab, diary, PK, IRT, etc.) align with clinical database data.
Perform QC of study documentation and Data Management Study File (DMSF).
Collaboration & Leadership
Lead cross-functional collaboration with Clinical Programming, Biostatistics, Clinical Operations, and vendors.
Act as the Non-CRF Point of Contact (POC) for customers, leading vendor communication and cross-functional tasks.
Support and back up PDMs, including sponsor updates, study metrics reporting, and resource coordination.
Provide EDC and project-specific training to internal/external teams.
Mentor and supervise other Clinical Data Associates, reviewing and guiding their work.
Compliance & Documentation
Participate in internal/external audits and inspections.
Maintain inspection-ready documentation in compliance with SOPs, GCP, ICH, and corporate guidelines.
Prepare reports such as SDRG/ADRG, DVS updates, and validated listing specifications.
Qualifications
Education
Bachelor’s degree in Biological Sciences, Natural Sciences, Health Care, or related field.
Experience
5–7 years of Clinical Data Management experience.
Strong background in non-CRF setup and external vendor data management.
Hands-on experience with central lab, eCOA, ePRO, patient diaries, device/sensor testing, ECG, IWRS/IVRS setup.
Knowledge of relational databases and Data Management systems (Oracle Clinical, Rave, Inform preferred).
Familiarity with medical terminology, ICH/GCP, and clinical trial processes.
Skills
Proficiency in MS Word, Excel, Windows, and email applications.
Excellent communication, interpersonal, and presentation skills.
Strong organizational and time management abilities; able to multitask under tight deadlines.
Leadership skills with proven mentoring and sponsor-facing experience.
Flexibility and adaptability to changing priorities.
Additional Information
Minimal travel may be required (up to 25%).
Responsibilities listed are not exhaustive; other duties may be assigned as per business needs.
Syneos Health values diversity, inclusion, and transferable skills – candidates are encouraged to apply even if not meeting every requirement.
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