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4-6 years
Not Disclosed
10 Dec. 5, 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

The Clinical Data Associate III role at Syneos Health involves managing various data management tasks related to clinical trials. Here’s a summary of the responsibilities and qualifications:

Key Responsibilities:

  • Project Management: Support project teams by maintaining awareness of contract and scope of work; providing status updates to Project Managers.
  • Data Management: Adhere to Clinical Data Management Plans, create and enter test data for User Acceptance Testing (UAT), review and resolve data discrepancies, and perform quality checks on databases.
  • EDC and Paper Studies: Handle both Electronic Data Capture (EDC) and paper-based data, perform quality control checks, and ensure proper documentation management.
  • Collaboration: Coordinate with other Data Operations teams like Safety, Biostatistics, and Clinical Programming.
  • Team Leadership: Provide training to less experienced Clinical Data Associates (CDAs) and ensure the team meets data management standards.
  • Clinical Data Cleaning: Perform data cleaning tasks, including query management and Serious Adverse Event (SAE) reconciliation.
  • Reporting: Generate data reports, perform post-migration testing, and track data management progress.

Required Qualifications:

  • Education: A BA/BS degree in biological sciences or related healthcare field.
  • Experience: 4-6 years of experience in clinical data management with strong skills in query management, vendor reconciliation, and lab query management.
  • Technical Skills: Hands-on experience with EDC platforms (e.g., Veeva, RAVE, INFORM), familiarity with Oncology trials is a plus.
  • Knowledge: Understanding of clinical data practices, Good Clinical Practices (GCP), and medical terminology.
  • Communication: Strong communication skills to interact with teams and stakeholders.
  • Leadership Skills: Ability to lead a team, mentor CDAs, and ensure adherence to data management practices.

Preferred Experience:

  • Experience in startup and closeout phases of trials, as well as proficiency with systems like Oracle Clinical or RAVE.
  • Exposure to Oncology trials is an added advantage.
  • Familiarity with data management systems like Oracle Clinical, RAVE, and Inform.

This position offers an opportunity to work in a dynamic and fast-paced environment with Syneos Health, a global leader in biopharmaceutical solutions.