Clinical Data Associate II
Updated: November 27, 2024
Location: India - Asia Pacific - IND-Home-Based
Job ID: 24006411
Job Description
Overview
Syneos Health® is a leader in biopharmaceutical solutions, committed to accelerating customer success through innovative clinical, medical, and commercial insights. Our approach places patients and customers at the center, driving impactful outcomes.
Work Here Matters Everywhere: Join our global team of 29,000 employees across 110 countries and make a difference in lives worldwide.
Why Syneos Health?
Career Advancement: Professional growth opportunities through training, mentorship, and career development programs.
Inclusive Culture: A commitment to diversity and authenticity through our Total Self culture.
Recognition & Rewards: Competitive benefits and programs to celebrate your contributions.
Key Responsibilities
As a Clinical Data Associate II, your primary responsibilities include:
Data Management:
Maintain awareness of project scope and contract elements.
Review and adhere to Clinical Data Management Plans (DMPs).
Conduct User Acceptance Testing (UAT) for data entry screens, edits, and listings.
Enter and validate lab normal ranges.
Data Review & Validation:
Identify and resolve data discrepancies using Data Validation Specifications (DVS).
Query and correct database entries as needed.
Reconcile Serious Adverse Events (SAEs) and perform quality checks on data listings.
Documentation:
Manage the Data Management Study File (DMSF).
Ensure proper filing and handling of case report forms (CRFs) and data clarification forms (DCFs).
Create electronic storage media and maintain study documentation.
Collaboration:
Participate in internal/external audits and team meetings.
Train and coordinate with other CDAs.
Ensure consistency between external datasets and clinical databases.
Technical Contributions:
Perform SAS mapping quality checks and create test data.
Run data cleaning/status reports and support coding processes.
Understand and support interim data cuts and study timelines.
Cross-Functional Coordination:
Collaborate with teams in Safety, Biostatistics, Clinical Programming, and Medical Writing.
Qualifications
Education & Experience:
BA/BS in biological sciences or a related field.
Experience in clinical research, data management, or drug development preferred.
Familiarity with Oracle Clinical, Rave, or Inform systems.
Technical Skills:
Proficiency in MS Windows, Word, Excel, and email applications.
Knowledge 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 multitask effectively.
Additional Requirements:
Minimal travel required (up to 25%).
Join Us
Over the past five years, Syneos Health has contributed to the development of 94% of FDA-approved drugs. Join our team to advance meaningful innovations in healthcare.
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Syneos Health is dedicated to fostering an inclusive and diverse workplace. If your experience does not perfectly align, we encourage you to apply, as we value transferable skills and unique perspectives.
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