3 часа назад
Site Management Lead (Clinical Trials)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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
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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