12 дней назад
Senior/Site Activation Specialist
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
Senior/Site Activation Specialist (Clinical Research): Coordinating clinical study start-up activities in Malaysia, including site feasibility, contracts, regulatory submissions, translations, and CTMS data entry with an accent on regulatory compliance, country-specific requirements, and document quality. Focus on preparing submission packages, resolving authority queries, negotiating site agreements, and maintaining critical documentation for study activation.
Location: Wilayah Persekutuan Kuala Lumpur, Malaysia
Company
provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Perform feasibility, site identification, contract negotiation, and other clinical study start-up activities.
- Prepare and coordinate submissions to regulatory authorities, ethics committees, and other relevant bodies.
- Develop, review, finalize, and translate study documents, including subject information sheets, informed consent forms, drug labels, and submission materials.
- Conduct quality reviews of submission packages and maintain regulatory documents, amendments, periodic updates, and safety letters.
- Track start-up activities in CTMS, follow up on ethics committee and competent authority queries, and maintain submission information.
- Coordinate materials for site initiation visits, collect critical documents for investigational product release, and support study team meetings.
Requirements
- Bachelor’s degree in life sciences or a related field and at least 3 years of clinical research or relevant experience, or an equivalent combination of education, training, and experience.
- Knowledge of clinical systems, procedures, corporate standards, the drug development process, and the regulated clinical trial environment.
- Knowledge of and ability to apply ICH GCP and applicable regulatory guidelines, including local regulations and standard operating procedures.
- Strong negotiation, communication, organizational, interpersonal, and influencing skills.
- Ability to work independently, prioritize tasks, resolve issues, and maintain effective relationships with colleagues, managers, clients, and authorities.
Culture & Benefits
- Full-time employment supporting clinical research and medical treatment development.
- Collaboration with local, regional, and country authorities, study teams, project teams, clients, and clinical research stakeholders.
- Work within established corporate standards, regulatory procedures, and quality requirements.
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