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Country Clinical Research Lead
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Country Clinical Research Lead (Clinical Trials/ICH-GCP): Managing operational delivery of strategic clinical studies in Germany with an accent on CRO oversight, country feasibility, regulatory submissions, and investigator relationships. Focus on meeting recruitment and sponsor deliverables, coordinating global clinical teams, and ensuring compliance with GCP, SOPs, and local regulatory requirements.
Location: Frankfurt, Hesse, Germany; candidates must be based in the listed location. Domestic and international travel, including overnight stays, may be required for up to approximately 20% of the working week.
Employment: Full time
Company
provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Oversee local CRO activities and serve as the single point of contact for strategic outsourced clinical studies.
- Coordinate with clinical study teams, global monitoring, clinical trial management, regulatory, quality assurance, and medical affairs functions.
- Support local EC submissions by ensuring the accuracy, consistency, customization, translation, and quality of core documents.
- Manage country feasibilities and assess competitive studies, marketed and non-marketed drugs, regulatory considerations, and standards of care.
- Build relationships with investigators and key opinion leaders and act as a site relationship partner throughout the study lifecycle.
- Support co-monitoring and CRA assessment visits when required.
Requirements
- At least 5 years of clinical research experience as a CRA, Lead CRA, or Project Manager.
- Bachelor’s or higher university degree in life sciences, nursing, or a medical field preferred.
- Knowledge of clinical trial methodology, drug development, clinical monitoring, GCP, SOPs, and country-specific regulatory requirements.
- Strong problem-solving, prioritization, organizational, time management, and independent working skills.
- Ability to establish and maintain effective relationships with internal and external stakeholders.
- Must be based in Frankfurt, Hesse, Germany; availability for domestic and international travel is required.
Culture & Benefits
- Work within a sponsor-dedicated Clinical Functional Service Partnerships department.
- Cooperate closely with a key client and participate in clinical research projects across different therapeutic areas.
- Work in accordance with ICH/GCP, sponsor SOPs, FDA regulations, and local regulatory requirements.
- Professional collaboration with global and local clinical research functions.
Hiring process
- Submit an English CV.
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