Job Title: Clinical Data Associate III – Immediate Joiners
Location: Remote, India
Job ID: 25104627
Category: Clinical Data Management / Healthcare
Company Overview:
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization committed to accelerating customer success. We deliver innovative clinical, medical affairs, and commercial solutions to address evolving healthcare challenges. Our Clinical Development model centers on the patient and customer, ensuring efficient, high-quality delivery of clinical trials and therapeutic solutions worldwide.
Join a global team of 29,000 professionals across 110 countries where your work directly impacts patient outcomes.
Role Overview:
We are seeking a highly skilled Clinical Data Associate III to support complex clinical trials and provide guidance to junior Clinical Data Associates (CDAs). The ideal candidate will possess expertise in clinical data management, electronic data capture (EDC) systems, and strong knowledge of regulatory standards. Immediate joiners are preferred.
Key Responsibilities:
Execute all clinical data management activities for complex trials with high accuracy.
Provide guidance, training, and mentorship to junior CDAs.
Review and adhere to study-specific Clinical Data Management Plans (CDMPs).
Perform User Acceptance Testing (UAT) for data entry screens, edit checks, and Targeted Source Data Verification (SDV) matrices.
Manage discrepancy resolution, query management, and re-queries per Data Validation Specifications (DVS) and Data Management Plans (DMP).
Conduct SAE reconciliations, PK/PD data reconciliation, and laboratory/vendor data review.
Support database design review, eCRF/CRF structuring, and data mapping activities.
Coordinate and verify data from external sources such as labs, IVRS, or electronic diaries against the clinical database.
Perform QC for paper and EDC studies, maintain documentation in Data Management Study Files (DMSF), and ensure compliance with ICH/GCP and SOPs.
Generate ad-hoc reports, data cleaning reports, and status summaries using CDMS tools (e.g., Oracle Clinical, Rave, or Inform EDC).
Assist Project Data Managers (PDMs) in updating DMPs, completion guidelines, and data transfer documentation.
Participate in internal and external audits, meetings, and sponsor calls as required.
Qualifications:
Bachelor’s degree in Biological Sciences, Life Sciences, or related healthcare field.
3–5 years of experience in Clinical Data Management.
Strong proficiency in EDC systems (Rave, Inform, Oracle Clinical) and clinical database management.
Experience with data validation, discrepancy management, query management, lab reconciliation, and SAE reconciliation.
Knowledge of ICH/GCP guidelines, medical terminology, and clinical trial processes.
Excellent communication, organizational, and time management skills.
Experience in vaccine or oncology therapeutic areas is preferred.
Familiarity with CPT/metrics, database closeout, and reporting is advantageous.
Ability to work independently and as part of a cross-functional team in a remote environment.
Minimal travel may be required (up to 25%).
Why Join Syneos Health:
Global exposure to cutting-edge clinical trials and healthcare projects.
Career development opportunities, technical training, and peer recognition.
Supportive and inclusive workplace with Total Self culture, fostering authenticity and belonging.
Opportunity to contribute to impactful clinical outcomes across therapeutic areas.
How to Apply:
Submit your application to join a global team dedicated to excellence in clinical data management and patient-focused outcomes. Immediate joiners will be prioritized.
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