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2-4 years
Not Disclosed
10 Nov. 29, 2024
Job Description
Job Type: Full Time Education: BA/BS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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!