5 дней назад
Regulatory and Start Up Specialist 2
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
Regulatory and Start Up Specialist 2 (Clinical Research): Managing country-level site activation and regulatory activities for clinical studies with an accent on document quality, regulatory compliance, and project timelines. Focus on coordinating investigative sites and project teams, tracking regulatory and ethics approvals, and applying GCP/ICH requirements.
Location: Sofia, Bulgaria
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, Site Activation Managers, project management, and internal departments.
- Perform country-level start-up and site activation activities in line with applicable regulations, SOPs, work instructions, and project requirements.
- Prepare, review, distribute, and track regulatory, ethics, informed consent, and investigator documentation.
- Maintain accurate project information in clinical systems, databases, tracking tools, and internal records.
- Review site performance metrics, perform document quality control, and provide feedback to management.
- Support project planning, timeline management, monitoring measures, and contingency planning.
Requirements
- Bachelor’s degree in life sciences or a related field, with at least 3 years of clinical research or relevant experience, or an equivalent combination of education, training, and experience.
- At least 3 years of clinical research experience, including 1 year in a leadership capacity.
- In-depth knowledge of clinical systems, procedures, corporate standards, and the regulated clinical trial environment.
- Knowledge of GCP/ICH and applicable local regulatory requirements, SOPs, and company standards.
- Strong communication, negotiation, organizational, interpersonal, and prioritization skills.
- Ability to manage multiple projects and build effective relationships with coworkers, managers, sites, sponsors, and clients.
Culture & Benefits
- Work within an international clinical research and healthcare intelligence organization.
- Collaborate with investigative sites, sponsors, project teams, and cross-functional departments.
- Operate in a quality-focused environment governed by regulatory requirements, SOPs, and corporate standards.
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