Company: Syneos Health
Location: India (Home-Based)
Job ID: 25002256
Syneos Health is a leading biopharmaceutical solutions organization, integrating clinical, medical affairs, and commercial insights to drive success in drug development. With 29,000 employees across 110 countries, we simplify clinical development to accelerate the delivery of life-changing therapies.
Join us—because work here matters everywhere.
Maintain awareness of contract scope and project elements.
Review and adhere to study-specific Clinical Data Management Plans.
Create and enter test data for User Acceptance Testing (UAT).
Perform User Acceptance Testing (UAT) for data entry screens, edits, and listings.
Receive and enter lab normal ranges.
Complete and submit Clinical Database Management System (CDMS) access forms.
Review discrepancy outputs and validation listings; apply corrections and resolve queries as per Data Validation Specification (DVS) and Data Management Plan (DMP).
Conduct Serious Adverse Event (SAE) reconciliations.
Perform QC checks for electronic and paper studies.
Ensure proper filing and tracking of Case Report Forms (CRFs) and Data Clarification Forms (DCFs).
Conduct quality review in Electronic Data Capture (EDC) systems.
Run data cleaning and study status reports.
Validate external datasets (lab data, electronic diary data, pharmacokinetic data, IRT, etc.) to ensure consistency with the clinical database.
Perform Standard Data Tabulation Model (SDTM) testing and SAS mapping QC.
Participate in internal/external audits and database finalization.
May coordinate and train Clinical Data Associates (CDAs) on data management activities and systems.
Provide accurate time estimates, prioritize multiple tasks, and adapt to changing timelines.
Maintain proficiency in Data Management systems and processes through ongoing training.
Education: BA/BS in biological sciences, health care, or related fields.
Experience:
Clinical Data Management (CDM) experience preferred.
Familiarity with Inform EDC systems, ICH-GCP, and clinical data processes.
Work experience in clinical research, drug development, or healthcare environment preferred.
Technical Skills:
Proficiency in MS Windows, Word, Excel, and email applications.
Strong keyboard speed and accuracy.
Familiarity with medical terminology.
Soft Skills:
Excellent communication, presentation, and organizational skills.
Ability to multi-task, prioritize, and work under tight deadlines.
Ability to work independently and in a multi-disciplinary team.
Other Requirements:
Minimal travel (up to 25%) may be required.
Worked with 94% of all Novel FDA-Approved Drugs in the past 5 years.
Collaborated on 95% of EMA-Authorized Products and 200+ studies across 73,000 sites.
Competitive career development, mentorship, and rewards program.
Be part of a diverse, inclusive, and innovative workplace.
We encourage applicants from diverse backgrounds and industries. If your experience doesn’t align perfectly, apply anyway—your skills may be transferable.
Join our Talent Network to stay updated on career opportunities at Syneos Health.
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