2 дня назад
Study Start Up Specialist (Clinical Research)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Study Start Up Specialist (Clinical Research): Managing country-level site activation and regulatory start-up activities for UK clinical trials with an accent on regulatory submissions, document quality, and project timelines. Focus on coordinating investigative sites and project teams, tracking approvals and essential documents, and applying UK clinical trial regulations and GCP/ICH requirements.
Location: Home-based in London, United Kingdom
Company
provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Serve as the single point of contact for investigative sites, Site Activation Managers, project management, and other departments.
- Perform country-level start-up and site activation activities in line with regulations, SOPs, work instructions, and project requirements.
- Prepare, review, distribute, and quality-control regulatory, ethics, informed consent, investigator pack, and contractual documents.
- Maintain clinical systems, databases, tracking tools, site records, timelines, and project-specific information.
- Track document approvals and execution, review site performance metrics, and support contingency planning.
- Provide UK regulatory and clinical trial expertise to Site Activation Managers and project teams, with occasional sponsor contact.
Requirements
- Bachelor’s degree in life sciences or a related field.
- At least 3 years of clinical research experience.
- In-depth knowledge of the UK clinical trial landscape and regulatory submissions.
- Knowledge of clinical systems, procedures, corporate standards, GCP/ICH, and applicable regulatory requirements.
- Understanding of the regulated clinical trial environment and drug development process.
Culture & Benefits
- Home-based working arrangement.
- Work within a global provider of clinical research and healthcare intelligence services.
- Role supporting the development and commercialization of innovative medical treatments.
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