Clinical Data Associate III (Central Lab)
Updated: November 28, 2024
Location: India - Asia Pacific - IND-Home-Based
Job ID: 24006415
Job Description
Overview
Syneos Health® is a global leader in biopharmaceutical solutions, driven to accelerate customer success through integrated clinical, medical, and commercial expertise. We focus on innovation, collaboration, and excellence to bring impactful solutions to the market.
Our Total Self culture fosters an inclusive environment where individuals can thrive authentically. With a global team of 29,000 employees across 110 countries, Work Here Matters Everywhere.
Why Syneos Health?
Career Growth: Continuous learning through training programs, mentorship, and progression opportunities.
Inclusive Culture: Valuing diverse backgrounds, experiences, and perspectives to foster innovation.
Rewards & Recognition: Competitive benefits and programs to celebrate achievements.
Key Responsibilities
As a Clinical Data Associate III, your role includes:
Project Management:
Maintain awareness of project contracts and scope of work.
Communicate updates to Project Managers or Biometrics Project Managers.
Data Review and Validation:
Perform User Acceptance Testing (UAT) for data entry screens, edits, matrices, and validation listings.
Handle discrepancy outputs, queries, and apply global rulings where necessary.
Reconcile data from external sources such as central labs, diaries, and PK data.
Documentation:
Maintain the Data Management Study File (DMSF).
Create and update Data Management Plans (DMPs), CRF/eCRF Completion Guidelines, and other project documents.
Participate in audits and ensure proper documentation of findings.
Quality Control:
Conduct internal QC checks for both paper and electronic studies.
Review and test database designs, configurations, and data validation specifications (DVS).
Team Collaboration:
Provide training to other CDAs on data management systems and processes.
Support Project Data Managers (PDMs) with document updates and sponsor communications.
Technical Contributions:
Design and review CRFs/eCRFs and visit structures.
Create and validate data cleaning reports and listings.
Perform post-migration testing and SAE reconciliations.
Cross-Functional Coordination:
Interact with Safety, Medical Writing, Biostatistics, Clinical Programming, and Coding teams to ensure data quality.
Qualifications
Education: BA/BS in biological sciences, healthcare, or a related field.
Experience:
Preferred background in clinical research, data management, or drug development.
Familiarity with relational database management systems, Oracle Clinical, Rave, or Inform systems.
Knowledge of ICH/Good Clinical Practices and medical terminology.
Technical Skills:
Proficient in MS Windows, Word, Excel, and email applications.
Excellent keyboard speed and accuracy.
Soft Skills:
Strong communication, organizational, and time-management abilities.
Ability to work under tight deadlines, multitask, and adapt to change.
A proactive team player with attention to detail.
Flexibility:
Minimal travel required (up to 25%).
Join Us
Syneos Health has supported the development of 94% of FDA-approved drugs over the past five years. Join our team to contribute to meaningful innovations in healthcare.
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Syneos Health is dedicated to building a diverse and inclusive workplace. If your experience does not perfectly align, we encourage you to apply, as we value transferable skills and diverse perspectives.
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