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Clinical Data Science Lead

Icon Plc
ICON PLC
10 Dec. 6, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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 Science Lead role at ICON plc involves leadership in clinical data management for clinical trials. Key responsibilities include:

Key Responsibilities:

  1. Leadership & Coordination:

    • Lead CROs, trial customers, and partners to align and confirm data management expectations.
    • Work with cross-functional teams to establish content and integration requirements for data collection tools (eCRF, etc.).
    • Set timelines and follow-up regularly to ensure Data Management milestones are met.
  2. Data Management & Oversight:

    • Ensure real-time inspection readiness of Data Management deliverables.
    • Oversee the preparation and quality of clinical data management documents, ensuring compliance with regulatory guidelines.
    • Plan and track deliverables such as CRFs, QC plans, oversight plans, and final datasets.
  3. Training & Communication:

    • Provide training and presentations at investigator and study team meetings.
    • Identify and communicate best practices and lessons learned across the trial.
  4. Project Management:

    • Manage multiple studies simultaneously while handling competing priorities.
    • Experience in vendor management, managing timelines, and interpreting clinical trial data.

Qualifications:

  • Experience: Minimum 5 years in Data Management for Clinical Trials (from start-up to database lock).
  • Skills:
    • Project management and vendor management experience.
    • Experience with SAS and SDTM datasets.
    • Strong communication and organizational skills.
  • Preferred:
    • Bachelor’s degree in Health or Science, with oncology experience.
    • Experience with Medidata RAVE.

Benefits:

  • Competitive salary and total reward packages.
  • Best-in-class employee benefits, including well-being initiatives.
  • A supportive environment that encourages professional development.

ICON is an equal-opportunity employer, committed to providing an inclusive and harassment-free work environment.