Job Title:
Clinical Data Associate (Central Lab DM)
Company:
Syneos Health
Location:
India-Asia Pacific - Home-Based, India
Job ID:
25003004
Job Type:
Full-Time
Role Overview:
The Clinical Data Associate (CDA) is responsible for assisting with all clinical data management activities for complex clinical trials. This includes guiding other CDAs, ensuring data integrity, addressing discrepancies, and supporting the collection and shipment of samples according to the study schedule.
Key Responsibilities:
Sample Data Management:
Reconcile eCRF informed consent information prior to shipment.
Address sample collection discrepancies with sites, monitors, and sponsors.
Communicate sample data information and shipping schedules to sponsors.
Review, clean, and provide updates on sample data.
Data Quality and Review:
Perform User Acceptance Testing (UAT) on data entry screens, edit checks, and SDV configuration.
Review and resolve queries from external data sources (e.g., PK, PD, biomarker data).
Review data in real-time, identify discrepancies, and initiate queries.
Database Management:
Perform quality checks (QC) on CRFs, DCFs, and electronic data capture (EDC) systems.
Manage and track data discrepancies and ensure database accuracy.
Perform post-migration testing and create specifications for validated listings.
Communication and Collaboration:
Communicate study progress and discrepancies to the project manager.
Participate in internal and external meetings, maintaining accurate meeting minutes.
Provide training to other CDAs on data management processes and systems.
General Responsibilities:
Coordinate the work of CDAs on assigned projects.
Conduct peer reviews and provide feedback on other CDAs' work.
Ensure compliance with study protocols and data management guidelines.
Prepare for and participate in audits, ensuring the integrity of clinical data.
Requirements:
Education:
BA/BS degree in biological sciences, healthcare, or a related discipline.
Experience:
Prior experience in clinical research, data management, or a related healthcare field is preferred.
Familiarity with clinical data management systems (e.g., Oracle Clinical, Rave, or Inform) and knowledge of ICH/Good Clinical Practices.
Skills:
Strong communication, organizational, and time management skills.
Ability to multitask and work under tight deadlines while maintaining attention to detail.
Proficiency with MS Office applications (Word, Excel, etc.) and clinical database management systems.
Why Syneos Health?
Syneos Health offers an environment where you can contribute to the development of innovative therapies and make a tangible impact in global clinical trials.
The company has worked with 94% of FDA-approved drugs and 95% of EMA-authorized products, playing a key role in advancing clinical research.
Gujarat :
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