Clinical Data Associate II - Syneos Health
About Syneos Health
Syneos Health is a globally integrated biopharmaceutical solutions organization, bringing innovative clinical, medical affairs, and commercial expertise to address modern healthcare challenges. With 29,000 employees across 110 countries, we are passionate about accelerating the delivery of life-changing therapies.
“Work Here Matters Everywhere.”
Key Responsibilities
Data Management and Quality Control
Conduct User Acceptance Testing (UAT) for data entry screens, edits, and review listings.
Manage lab normal ranges and submit Clinical Database Management System (CDMS) access forms.
Review discrepancy outputs, issue queries, and make corrections per Data Validation Specifications (DVS).
Ensure consistency between databases and external datasets, including lab data and pharmacokinetic (PK) data.
Perform Serious Adverse Event (SAE) reconciliations and generate data cleaning reports.
Study Coordination
Oversee paper and electronic studies, including data tracking, CRF review, and document filing.
Coordinate internal quality checks and electronic data capture (EDC) processes.
Manage database locking, freezing, and closeout processes.
Documentation and Training
Prepare and maintain study-specific Clinical Data Management Plans (DMP).
Mentor team members and provide training on data management systems.
Create test data for Standard Data Tabulation Model (SDTM) and conduct SAS mapping quality control.
Qualifications
Education and Experience
Bachelor’s degree in biological sciences, natural sciences, or healthcare-related field.
2–4 years of experience in clinical data management, with Central Lab (Non-CRF data) experience as a plus.
Experience with Query Management, Spotfire, Vendor & SAE Reconciliation, and Lab Query Management preferred.
Technical Skills
Proficiency with Oracle Clinical, Rave, or Inform systems preferred.
Familiarity with ICH/Good Clinical Practices and medical terminology.
Strong proficiency in MS Windows, Word, Excel, and email applications.
Soft Skills
Excellent communication, organizational, and time management skills.
Ability to prioritize and adapt in a dynamic environment.
Strong team collaboration and independent work capabilities.
Why Join Syneos Health?
Career Growth
Opportunities for career progression, technical training, and peer recognition.
Supportive and engaged leadership to guide your professional development.
Inclusive Culture
A Total Self culture that values diversity, equity, and authenticity.
Global Impact
Contribute to the development of therapies used by 94% of all FDA-approved drugs in the past five years.
Application Details
Ready to make a difference? Apply Now through Syneos Health’s career portal or join our Talent Network to stay updated on future opportunities.
At Syneos Health, we welcome applicants with diverse backgrounds and transferable skills.
Join us in driving innovation and improving lives globally!
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