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5 часов назад

Medical Scientist Lead

Тип работы
fulltime
Грейд
lead
Английский
c1
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Medical Scientist Lead (Clinical Trials): Leading Medical Scientist and Medical Specialist teams while supporting medical monitoring, clinical data review, and study documentation for clinical trials with an accent on ICH GCP compliance, operational delivery, and cross-functional collaboration. Focus on supervising staff, coordinating study start-up and execution, reviewing medical data and TMF documentation, and supporting audits and regulatory inspections.

Location: United States of America

Company

hirify.global supports biotech, medtech, and specialty pharmaceutical companies in developing medicines, medical devices, and diagnostics through clinical research and medical affairs services.

What you will do

  • Manage and supervise Medical Scientist and Medical Specialist staff, including hiring, onboarding, mentoring, performance management, resource planning, and operational direction.
  • Define and communicate project-specific requirements for medical scientist and specialist activities supporting medical monitoring.
  • Collaborate with Medical Monitors and Medical Directors on clinical studies, monitoring plans, site and project team queries, medical data review, and eligibility and enrollment assessments.
  • Coordinate study start-up and execution, including process documentation, budget and scope tracking, medical data review, TMF filing, quality control, and issue resolution.
  • Ensure compliance with ICH GCP, ICH E2A, national regulations, applicable agency guidance, and standard operating procedures.
  • Support audits and regulatory inspections, evaluate technology tools for study processes, and contribute to corporate technology and process initiatives.

Requirements

  • Advanced degree in a medical or scientific field, such as a PhD or MD.
  • 2–4 years of relevant experience in a CRO, pharmaceutical, or medical organization.
  • Working knowledge of ICH GCP regulations, agency guidance documents, applicable regulations, and procedures.
  • Fluent written and spoken English and the applicable local language or languages.
  • Proficiency with Microsoft Word, Excel, web-based communication tools, and relevant industry technology platforms.
  • Strong leadership, collaboration, communication, negotiation, organizational, and time-management skills, with the ability to manage changing priorities.

Culture & Benefits

  • Work in an environment focused on medical innovation and improving patient outcomes.
  • Access opportunities to develop skills and grow professionally.
  • Flexibility and balance are supported alongside work responsibilities.
  • Employee ideas and participation in company initiatives are encouraged.

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