5 часов назад
Senior Site Activation Specialist (m/w/d) (Clinical Research)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Site Activation Specialist (Clinical Research): Coordinating clinical research site activation activities across Germany with an accent on regulatory submissions, site contracts and budgets, document quality control, and study timelines. Focus on securing ethics and regulatory approvals, tracking site performance, and maintaining compliance with GCP, ICH, SOPs, and project requirements.
Location: Home-based within Germany; Frankfurt, Hesse
Company
provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Act as the single point of contact for investigative sites and internal clinical operations, feasibility, site identification, project management, and client stakeholders.
- Perform regulatory, study start-up, and site maintenance activities in line with applicable regulations, SOPs, work instructions, and project requirements.
- Prepare, review, and negotiate site contracts and budgets, and verify the completeness and accuracy of regulatory documents.
- Submit approval requests to local regulatory and ethics committees and track contracts, approvals, ICF, IP Release, and other project deliverables.
- Maintain accurate project information in internal systems, databases, and tracking tools while managing timelines, monitoring measures, and contingency plans.
- Review site performance metrics and provide feedback to management.
Requirements
- University degree in life science or another scientific discipline, or an apprenticeship in healthcare, legal secretarial work, or paralegal studies.
- Clinical research experience, preferably in study start-up, or an equivalent combination of education, training, and experience.
- Knowledge of clinical research regulations, Good Clinical Practice, and ICH guidelines.
- Fluent German at C1 level or higher and good command of English required.
- Strong written and verbal communication skills, attention to detail, and the ability to prioritize multiple tasks.
Culture & Benefits
- Supportive leaders, mentors, and teams.
- Career development resources and exposure to dynamic work environments.
- Flexible working schedule and home-office arrangement.
- Competitive salary, bonus system, and pension benefits.
Hiring process
- Submit an English CV and motivation letter.
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