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1+ 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

Job Opportunity: Clinical Data Associate II at Syneos Health


About Syneos Health

Syneos Health is a fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We deliver innovative clinical, medical affairs, and commercial insights to address the complexities of modern healthcare markets.

Join 29,000 global professionals working across 110 countries to transform lives. At Syneos Health, “Work Here Matters Everywhere.”


Key Responsibilities

Data Management and Compliance

  • Adhere to study-specific Clinical Data Management Plans and contracts.
  • Perform User Acceptance Testing (UAT) and enter test data for clinical database systems.
  • Conduct data reviews, resolve discrepancies, and apply corrections according to the Data Validation Specifications (DVS) and/or Data Management Plan (DMP).
  • Maintain quality and compliance with ICH/GCP guidelines and corporate procedures.

Coordination and Support

  • Manage data integration from external sources, ensuring consistency and accuracy.
  • Create electronic storage media for EDC studies and maintain Data Management Study Files (DMSF).
  • Conduct Serious Adverse Event (SAE) reconciliations and assist with interim, dry run, and data cut processes.
  • Train and mentor team members on data management systems and procedures.

Quality Control and Reporting

  • Run data cleaning and status reports.
  • Ensure timely task completion by prioritizing workload and adapting to shifting deadlines.
  • Participate in audits, ensuring documentation is audit-ready and up to date.
  • Coordinate work across teams, contributing to a high-functioning multidisciplinary environment.

Qualifications

Education and Experience

  • BA/BS in life sciences, nursing, or related fields. Equivalent work experience may be considered.
  • Experience in data management, clinical research, or healthcare.
  • Familiarity with Oracle Clinical, Rave, or Inform systems preferred.

Skills and Knowledge

  • Understanding of clinical data, medical terminology, and ICH/GCP practices.
  • Proficiency in Microsoft Office applications (Word, Excel, PowerPoint) and email systems.
  • Excellent communication, organizational, and multitasking skills.
  • Ability to work independently and collaboratively within a team.
  • Flexible and adaptive to change with strong attention to detail.

Additional Requirements

  • Minimal travel may be required (up to 25%).
  • Responsible for compliance with corporate business practices and procedures.

Why Join Syneos Health?

Career Growth

  • Access to professional development and career progression opportunities.

Inclusive Culture

  • A workplace where you can authentically be yourself.

Global Impact

  • Play a pivotal role in delivering therapies that transform lives.

Diversity and Innovation

  • Collaboration across diverse teams and perspectives to foster creativity and innovation.

Application Details

  • Apply Now on Syneos Health's career portal.
  • Not ready to apply? Join the Talent Network for future updates.

At Syneos Health, we value transferable skills and diverse experiences. We encourage applications from all qualified candidates.


For more information, visit Syneos Health’s website. Be part of our mission to change lives.