6 дней назад
Senior Lead, Clinical Project Manager
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Lead, Clinical Project Manager (Clinical Research): Leading global clinical study management and project delivery for clinical development programs with an accent on governance, risk mitigation, cross-functional execution, and regulatory compliance. Focus on managing complex studies, improving operational workflows, and coaching project management teams.
Location: United States Remote
Company
, part of Thermo Fisher Scientific, develops solutions that help unlock better evidence and support the delivery of life-changing therapies to patients.
What you will do
- Provide leadership and governance for global clinical study management and project delivery, keeping programs on schedule, within budget, and aligned with contractual obligations.
- Evaluate study progress, resource allocation, workloads, risks, escalations, and operational challenges, implementing mitigation strategies and maintaining appropriate documentation.
- Lead communication and collaboration with sponsors, internal stakeholders, cross-functional teams, and geographically dispersed study teams.
- Serve as Project Manager for complex customer programs when required, overseeing study start-up, execution, and closeout activities.
- Drive process improvement, operational readiness, departmental initiatives, SOP compliance, and regulatory-quality standards across therapeutic or imaging teams.
- Coach, mentor, develop, onboard, and manage the assignments and performance of Project Management team members.
Requirements
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related discipline; a Master’s degree is preferred.
- 5–10 years of clinical research experience in a CRO, pharmaceutical, biotechnology, or related clinical development environment, including significant project management responsibility.
- Previous people management and leadership experience in clinical development, clinical operations, or clinical trial management.
- Strong knowledge of clinical trial processes, project management methodologies, drug development practices, GCP, ICH guidelines, and FDA regulations.
- Experience supporting global clinical studies and leading cross-functional, geographically dispersed teams; excellent English communication skills are required.
- Valid passport and ability to travel up to 20% as needed.
Nice to have
- Master’s degree in a relevant discipline.
- Medical Imaging experience.
Culture & Benefits
- Work on clinical development programs intended to help bring therapies to patients faster.
- Collaborate with global and geographically dispersed teams.
- Participate in continuous process improvement, training, and professional development initiatives.
- Operate within established departmental standards, company policies, SOPs, and regulatory requirements.
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