Senior Clinical Research Scientist

hace 1 semana

Madrid, Madrid, España Engineeringuk A tiempo completo

Job Summary:

We are seeking a highly skilled Senior Clinical Scientist to join our team at ICON. As a Senior Clinical Scientist, you will be responsible for leading medical data reviews and developing study-specific Table of Contents (TOC) if needed. You will also be responsible for reviewing safety TFLs at a frequency specified in the data review plan and developing a Safety Slide Deck (SSD) for cross-functional review.

Key Responsibilities:

  • Preparation of a medical data review plan, including determining data retrieval strategies required per MRP/protocol.
  • Development of a study-specific Table of Contents (TOC) if needed, providing support and suggestions on how to best process data available in the clinical database to serve compound/study needs.
  • Review of safety TFLs at a frequency specified in the data review plan.
  • Development of a Safety Slide Deck (SSD) for cross-functional review, with specific attention to Adverse Events (TEAE, Related TEAE), Treatment Emergent Serious Adverse Events (TESAE), Adverse Events of Special Interest (AESI), Worst Post Baseline Laboratory Shift Tables, Laboratory abnormalities, Important medical protocol deviations, Study Status Summary Table, AE Summary, SAE Summary, and Query identifiable safety-related medical discrepancies or requests for clarification in the appropriate ED.
  • Preparation of a summary of the safety data review, including data reviewed, data safety findings observed, a summary of data cleaning requests/observations, and any input from stakeholder review.
  • Additional Data Review or Compilation, including review of patient-specific and overall safety data presented in the clinical study report (CSR) and preparation of the medical protocol deviations for cross-functional review.

Requirements:

  • Experienced in medical data review.
  • Previous experience in clinical trials and clinical trial setup.
  • Data management experience in life science/pharma.
  • Experience in one of the following Therapeutic Areas (TA): cardiovascular/renal, ophthalmology, cell and gene therapy, and oncology.

What We Offer:

At ICON, we value diversity, inclusion, and belonging. We offer a competitive salary, a range of additional benefits, and opportunities for career growth and development. Our success depends on the quality of our people, and we strive to build a diverse culture that rewards high performance and nurtures talent.

Benefits:

  • Competitive salary.
  • Various annual leave entitlements.
  • A range of health insurance offerings to suit you and your family's needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialized professionals.
  • Life assurance.
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Learn More:

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

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