4 дня назад
Clinical Trial Manager
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
Clinical Trial Manager (Clinical Research): Managing the planning, execution, and close-out of global Phase 1–3 clinical trials with an accent on cross-functional leadership, vendor and site oversight, regulatory compliance, and study budget and timeline control. Focus on coordinating complex clinical operations, maintaining trial systems and documentation, supporting audits and regulatory submissions, and resolving operational challenges across internal and external partners.
Location: Malvern, Pennsylvania, United States; in-person office setting
Company
discovers, develops, and commercializes gene and cell therapies and vaccines, including therapies for retinal and orthopedic diseases.
What you will do
- Lead the planning, execution, and delivery of global Phase 1–3 clinical studies in accordance with GCP/ICH guidelines, SOPs, and regulatory requirements.
- Own study operational plans, timelines, enrollment projections, budgets, risk mitigation, and process improvements.
- Manage CROs and other vendors, including selection, contracting, scope development, and performance oversight.
- Lead internal and external clinical study teams and oversee site identification, qualification, initiation, training, and communications.
- Contribute to protocols, amendments, CRFs, ICFs, study reports, annual reports, investigator brochures, publications, and scientific communications.
- Coordinate with Clinical, Regulatory, Quality, Finance, and external partners on audit readiness, regulatory submissions, safety board reviews, and study execution.
Requirements
- Bachelor’s degree in life sciences or a related field.
- At least 5 years of clinical research experience in biotech or pharma, including 2 or more years as a Clinical Trial Manager.
- Experience managing global Phase 1–3 trials and overseeing vendors and CROs.
- Strong knowledge of ICH-GCP, FDA, and international clinical trial regulations.
- Experience with clinical trial systems such as CTMS, eTMF, and EDC.
- Ability to lead cross-functional teams, manage complex studies, resolve operational challenges, and communicate effectively.
Nice to have
- Advanced degree in a relevant field.
- Experience in ophthalmology or advanced therapy studies.
- Experience with SAS.
Culture & Benefits
- In-person work in an office setting.
- Availability outside regular hours may be required for priority business needs.
- Work in a fast-paced, collaborative environment focused on advancing gene and cell therapies and vaccines.
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