Job Title: Senior Clinical Data Associate – Immediate Joiners
Location: Remote, India
Job ID: 25104628
Category: Clinical Data Management / Healthcare
Company Overview:
Syneos Health® is a global leader in fully integrated biopharmaceutical solutions, committed to accelerating clinical development and patient-centric outcomes. Our Clinical Development model centers on patients and customers, delivering innovative, high-quality clinical trials worldwide. With 29,000 employees across 110 countries, we combine expertise, technology, and collaboration to advance therapies efficiently and safely.
Role Overview:
We are seeking a Senior Clinical Data Associate (SCDA) to lead Clinical Data Associates (CDAs) in executing end-to-end data management activities for global clinical trials. The role may also serve as a backup for the Project Data Manager (PDM), ensuring compliance with ICH/GCP, SOPs, and study-specific Data Management Plans (DMP). Immediate joiners are preferred.
Key Responsibilities:
Lead and mentor CDAs in day-to-day clinical data management activities.
Oversee end-to-end study data processes including study startup, conduct, and closeout.
Perform User Acceptance Testing (UAT) for data entry screens, edit checks, listings, and SDV matrices.
Manage discrepancy resolution, query management, SAE reconciliations, and vendor data reconciliation (Lab, PK/PD, IVRS, IRT).
Review CRF/eCRF design, annotated CRFs, DVS, and other study-specific documents.
Ensure alignment of data from external sources (labs, electronic diaries, PK/PD data) with clinical databases.
Conduct QC for paper and EDC studies; maintain documentation in Data Management Study Files (DMSF).
Generate ad-hoc data cleaning and status reports, and support post-migration testing.
Serve as a subject matter expert (SME) for platform/process-specific data management tasks and EDC training.
Participate in internal and external audits, meetings, and sponsor calls as required.
Support Project Data Manager (PDM) in project-specific responsibilities, including metrics reporting, document updates, and sponsor communication.
Qualifications:
Bachelor’s degree in Biological Sciences, Life Sciences, or related healthcare field.
5+ years of experience in Clinical Data Management practices, including study startup, conduct, and closeout.
Proficiency in EDC systems such as Oracle Clinical, Rave, or Inform; knowledge of ICH/GCP guidelines and clinical data standards.
Expertise in query management, discrepancy resolution, SAE reconciliation, lab/vendor data reconciliation, metrics (CPT), and database locking/freezing.
Client-facing experience and ability to work independently with minimal supervision.
Strong communication, organizational, planning, and leadership skills.
Familiarity with coding, TMF review, and post-production changes is a plus.
Ability to mentor and train junior CDAs effectively.
Proficiency in MS Office applications (Word, Excel, Outlook).
Remote work flexibility; minimal travel may be required (up to 25%).
Why Join Syneos Health:
Work on global clinical trials with high-impact therapeutic outcomes.
Access career development, technical training, and peer recognition programs.
Inclusive Total Self culture encouraging authenticity, collaboration, and diversity.
Opportunity to influence and improve data management processes in a leading biopharmaceutical environment.
How to Apply:
Apply now to join a global team dedicated to clinical excellence and patient-focused outcomes. Immediate joiners will be given priority consideration.
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