12 дней назад
Senior Clinical Trial Manager (Clinical Research)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Clinical Trial Manager (Clinical Research): Managing multinational clinical trials from feasibility and site selection through study completion with an accent on timelines, budgets, patient recruitment, vendor coordination, and regulatory compliance. Focus on leading multidisciplinary teams, managing complex trials, resolving data discrepancies, and maintaining Good Clinical Practice standards.
Location: United States
Company
is a global biopharmaceutical company developing and commercializing therapeutics in Hematology, Oncology, Inflammation, and Autoimmunity.
What you will do
- Deliver multinational clinical trials on time, within budget, and to the highest achievable quality.
- Manage trial timelines, budgets, priorities, feasibility, investigative site selection, and patient recruitment plans.
- Coordinate CROs and other vendors, review monitoring reports, and conduct co-monitoring visits as needed.
- Support the development and review of protocols, clinical trial documents, manuals, regulatory materials, and clinical study reports.
- Lead multidisciplinary trial teams, coordinate internal stakeholders, and provide progress updates to management.
- Monitor study safety and quality metrics while ensuring adherence to Good Clinical Practice and applicable regulations.
Requirements
- BS/BA degree or a relevant science-focused degree, or equivalent experience.
- Experience in biopharmaceutical or clinical research, including the conduct and management of multinational clinical trials.
- Experience managing complex and/or large clinical trials and a broad range of trial activities from initiation through the clinical study report.
- Working knowledge of ICH Good Clinical Practice and relevant regulatory or health authority requirements.
- Strong leadership, problem-solving, planning, prioritization, organization, communication, and stakeholder-management skills.
- Ability to manage multiple priorities across several protocols and therapeutic areas in a multidisciplinary environment.
Culture & Benefits
- Work within a global biopharmaceutical organization with operations across North America, Europe, and Asia.
- Collaborate with multidisciplinary internal teams, CROs, and other third-party vendors.
- Participate in working groups and special projects focused on improving development operations efficiency and quality.
- Employment with an equal opportunity organization committed to a diverse working environment.
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