9 дней назад
Clinical Project Manager (Clinical Research)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Project Manager (Clinical Research): Leading regional clinical study delivery from feasibility through closeout with an accent on operational planning, regulatory submissions, vendor coordination, and inspection readiness. Focus on managing regional teams and budgets, ensuring ICH/GCP compliance, resolving site and data issues, and aligning regional execution with global study goals.
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
- Lead regional clinical operations teams, external vendors, and cross-functional stakeholders across assigned studies.
- Plan and manage regional clinical projects from feasibility through closeout, aligning delivery with global timelines, budgets, and study objectives.
- Coordinate feasibility, country allocation, site selection, study start-up, recruitment timelines, regulatory submissions, and local document adaptations.
- Oversee site execution, monitoring reports, Trial Master File quality control, drug inventory inputs, data collection, query resolution, and investigator payments.
- Manage escalated site issues, regional resources, contingency planning, and budget utilization.
- Drive inspection readiness, audit preparation, corrective responses, process improvements, and collaboration with global project teams.
Requirements
- Bachelor's degree in life sciences or a related field.
- Progressive clinical research experience in the biotech, pharmaceutical, or CRO industry.
- At least 7 years of monitoring experience, including more than 1 year of project management experience, or an equivalent combination of education, training, and experience.
- Knowledge of clinical trial conduct, ICH GCP, and applicable local laws, regulations, and guidelines.
- Good command of English, with strong written, verbal, and presentation skills.
Culture & Benefits
- Full-time role focused on regional clinical study delivery.
- Collaboration with global clinical project managers, country teams, CRAs, regulatory affairs, medical writing, sourcing, and clinical business operations.
- Work includes maintaining quality, compliance, and inspection readiness throughout the study life cycle.
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