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3 часа назад

Site Management Lead (Clinical Trials)

Формат работы
onsite
Тип работы
fulltime
Грейд
lead
Английский
c1
Страна
Germany
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
Site Management Lead (Clinical Trials): Leading site monitoring strategy, risk assessments, oversight plans, and execution for assigned clinical trials with an accent on patient safety, ICH-GCP compliance, and sponsor oversight. Focus on identifying and mitigating trial-level risks, overseeing CRO performance, managing complex trials across regions and vendors, and maintaining inspection readiness.

Location: Frankfurt, Hesse, Germany

Company

hirify.global provides clinical research services, commercial insights, and healthcare intelligence to life sciences and healthcare organizations.

What you will do

  • Lead trial quality and risk monitoring preparation, including risk assessments, mitigation strategies, and Site Monitoring & Oversight plans.
  • Oversee the implementation of site monitoring activities and maintain sponsor oversight across assigned clinical trials.
  • Provide guidance, training, and subject-matter expertise to CT Managers, CRAs, and trial teams.
  • Oversee CRO performance, identify trial and site-level risks, and drive issue resolution and follow-up actions.
  • Lead trial oversight meetings, document amendments, retraining activities, and stakeholder communications.
  • Coordinate clinical trial data cleaning and support quality reporting during close-out.

Requirements

  • University degree in life sciences or a related field, or equivalent professional education with extensive clinical operations and site monitoring experience.
  • At least five years of relevant clinical operations experience.
  • Fluent English.
  • Profound CRA experience with Lead-level CRA responsibilities and initial exposure to Clinical Trial Management tasks.
  • Deep knowledge of ICH-GCP, regulatory requirements, and risk-based monitoring.
  • Experience managing complex trials across regions and vendors, with strong leadership and influencing skills.

Culture & Benefits

  • Full-time employment within the Clinical Functional Service Partnerships department.
  • Work with global clinical trial teams and stakeholders across regions.
  • Focus on patient safety, reliable trial results, regulatory compliance, and inspection readiness.

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