2 дня назад
Senior Clinical Project Manager (Clinical Trials)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Clinical Project Manager (Clinical Trials): Leading and coordinating complex clinical trials for pharmaceutical, biotechnology, medical device, and consumer health clients with an accent on cross-functional delivery, regulatory compliance, and sponsor management. Focus on managing study timelines and budgets, coordinating clinical operations teams, and ensuring adherence to GCP/ICH guidelines and applicable regulations.
Location: Germany. Permanent remote work is available, with a potential hybrid arrangement depending on location.
Company
is a global full-service CRO providing clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.
What you will do
- Lead and coordinate complex clinical projects, including project-specific services, timelines, budgets, documentation, and quality requirements.
- Coordinate Sponsors, Investigators, Clinical Research Associates, Clinical Research Administrators, Biometrics, Safety, Regulatory, and other project stakeholders.
- Monitor project team workload and performance, organize team activities, and provide regular status updates to project leadership and Sponsors.
- Manage regulatory submissions, study documentation, archiving, trainings, Monitor and Investigator Meetings, and periodic project meetings.
- Support protocol, Case Report Form, and final Clinical Study Report preparation with the Medical Monitor.
- Act as a technical specialist or mentor for Project Coordinators and Project Manager I, and contribute to SOP development and procedure compliance.
Requirements
- At least 8 years of clinical research project management experience.
- Previous CRO experience is required.
- Experience managing respiratory, rare disease, general medicine, or GLP-1 studies is required.
- Bachelor’s degree or equivalent in a scientific, medical, paramedical, or nursing discipline, or equivalent relevant experience.
- Strong knowledge of clinical trial operations, GCP/ICH guidelines, and applicable regulatory requirements.
- Fluent English is required. Proficiency in Microsoft Office is also required.
Nice to have
- Previous Clinical Research Associate or Clinical Monitor experience.
- Experience with electronic data capture systems.
Culture & Benefits
- Permanent remote work with potential hybrid flexibility depending on location.
- Work-life balance supported by a collaborative, quality-driven one-team culture.
- Continuous professional development, training, and mentoring.
- Work with global pharmaceutical, biotechnology, medical device, and consumer health projects.
- Diverse and inclusive international workforce across more than 20 countries.
Hiring process
- Submit a CV and receive an application acknowledgement.
- Qualified candidates are invited to a phone interview as the first step.
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