Clinical Data Associate III (Data Acquisition Specialist)
Updated: November 28, 2024
Location: India - Asia Pacific - IND-Home-Based
Job ID: 24006408
Job Description
Overview
Syneos Health® combines clinical, medical, and commercial expertise to drive biopharmaceutical innovation and accelerate customer success. With a focus on simplifying processes and putting the patient first, we aim to deliver therapies that transform lives.
Work Here Matters Everywhere: Join our global network of 29,000 employees in over 110 countries, contributing to the success of life-changing healthcare solutions.
Why Syneos Health?
Career Development: Opportunities for professional growth through training, mentorship, and progression programs.
Inclusive Culture: Emphasis on diversity and inclusion through our Total Self culture.
Recognition & Benefits: Comprehensive rewards and peer recognition programs.
Key Responsibilities
Data Management and Testing:
Manage study-specific Clinical Data Management Plans (DMPs).
Perform User Acceptance Testing (UAT) for data entry screens, edits, and configurations.
Coordinate with project managers and provide regular updates on project scope and status.
Data Cleaning and Validation:
Perform quality checks and resolve discrepancies in clinical databases.
Validate and correct data entry, ensuring consistency across datasets.
Conduct Serious Adverse Event (SAE) reconciliations and peer reviews.
Documentation and Reporting:
Maintain and update the Data Management Study File (DMSF).
Develop data cleaning reports and update documentation such as DMPs and CRF/eCRF guidelines.
Support data migration testing and create post-migration reports.
Collaboration and Coordination:
Provide project-specific training to Clinical Data Associates (CDAs).
Coordinate the work of CDAs across projects, ensuring alignment with study protocols.
Participate in audits, customer meetings, and provide regular feedback to the team.
Technical Contributions:
Design and review CRF/eCRF structures.
Create data validation specifications and edit checks.
Generate reports using tools like Discoverer, BOXI, and J-Review.
Manage data transfers and ensure compliance with Trusted Processes (TP).
Cross-functional Interaction:
Collaborate with Safety, Medical Writing, Biostatistics, and Clinical Programming teams.
Ensure integration of external datasets (e.g., laboratory, diary, pharmacokinetic data) with clinical databases.
Qualifications
Education & Experience:
BA/BS in biological sciences or a related field.
Experience in clinical research, data management, or drug development preferred.
Technical Skills:
Knowledge of Oracle Clinical, Rave, or Inform systems.
Proficiency in MS Office applications.
Understanding of ICH/Good Clinical Practices and medical terminology.
Soft Skills:
Strong communication and interpersonal abilities.
Excellent organizational and time-management skills.
Flexibility to adapt to changing priorities and work independently or as part of a team.
Additional Requirements:
Minimal travel required (up to 25%).
Join Us
Syneos Health has contributed to the development of 94% of FDA-approved drugs over the past five years. Join our team to make a global impact in advancing healthcare solutions.
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At Syneos Health, we value transferable skills and encourage applicants from diverse backgrounds. If your experience doesn’t align perfectly, consider applying anyway.
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