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Clinical Data Science Lead

0-2 years
Not Disclosed
10 Dec. 6, 2024
Job Description
Job Type: Full Time Education: BS/BA 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 involves providing scientific support for clinical data review in collaboration with the Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS). This position focuses on data management activities for clinical trials, particularly those involving complex medical indications and therapy-related elements.

Key Responsibilities:

  1. Scientific Data Review:

    • Perform complex clinical data reviews in collaboration with SRP, SRS, and Data Management functions.

    • Review data flows and Data Management Plans, ensuring ongoing data review activities meet quality standards.

    • Provide input into study-specific and indication-specific data collection tools.

  2. Collaboration & Leadership:

    • Collaborate with SRP/SRS, Data Management, and other study team members to establish expectations for clinical data review.

    • Lead meetings and discussions with clinical teams to align on data-related activities and milestones.

  3. Review & Troubleshooting:

    • Manage queries in eDC systems and address complex scientific study data issues.

    • Involvement in additional review activities like coding and SAE reconciliation.

  4. Trial Oversight:

    • Review content and integration requirements for eCRF and data collection tools.

    • Ensure timely delivery of all Data Management milestones and track progress with the study team.

Qualifications:

  • Education: BS/BA degree (preferably in Health Sciences or related field).

  • Experience:

    • Experience in Data Management or clinical data review.

    • Knowledge of medical terminology is beneficial.

    • Experience in clinical drug development within the pharmaceutical industry.

    • Strong collaboration skills with clinical teams.

Benefits:

  • Competitive salary and a range of benefits, including health insurance, life assurance, and global employee assistance programs.

  • Work-life balance opportunities such as various annual leave entitlements, retirement planning, and flexible country-specific benefits.

  • ICON is an equal-opportunity employer, fostering a diverse and inclusive work environment.

ICON is committed to providing an accessible and harassment-free workplace for all candidates.