8 дней назад
Regulatory & Start Up Specialist 1 (Clinical Research)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Regulatory & Start Up Specialist 1 (Clinical Research): Driving study start-up, site activation, and regulatory document management for clinical research sites in Chile with an accent on regulatory compliance, document quality, and project timelines. Focus on coordinating investigative sites and project teams, tracking approvals and contracts, and solving complex operational issues across multiple priorities.
Location: Full home-based role in Santiago, Chile
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 other departments.
- Execute study start-up and site activation activities in accordance with regulations, SOPs, and work instructions.
- Prepare, review, distribute, and quality-check site regulatory, ethics, informed consent, investigator pack, and contractual documents.
- Maintain project information in internal systems, databases, tracking tools, and site performance metrics.
- Track document approvals, execution, and release against project timelines, escalating risks and implementing contingency plans when needed.
- Provide local expertise and planning support to Site Activation Managers and project teams, with occasional sponsor contact.
Requirements
- Bachelor's degree in life sciences.
- At least 1 year of clinical research and study start-up management experience.
- Fluent English for written and oral communication.
- Strong analytical and critical-thinking skills, including the ability to evaluate complex issues from multiple perspectives.
- Interpersonal skills for building trust and communicating clearly in changing environments.
- Successful execution skills and the ability to manage multiple priorities in a fast-paced setting.
Culture & Benefits
- Full-time employment.
- Home-based work arrangement.
- Work within a global clinical research and healthcare intelligence organization.
- Work governed by standard operating procedures, work instructions, quality requirements, and project timelines.
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