обновлено 11 дней назад
Senior Clinical Systems Manager (Pharma)
260 000 - 260 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Clinical Systems Manager (Pharma): Delivering high-quality, data-driven feasibility assessments across all phases of clinical development with an accent on early indication assessments, study-level feasibility, country and site identification, investigator outreach, and enrollment forecasting. Focus on translating feasibility insights into actionable inputs for program and study team decision-making and collaborating with site management functions.
Location: Plainsboro, New Jersey, United States
Salary: $260,000 per year
Company
provides staffing and employment services for specialized professional roles.
What you will do
- Support end-to-end feasibility activities across clinical development programs and studies.
- Deliver early indication and study-level feasibility assessments, including competitive landscape reviews and operational risk identification.
- Develop country and site identification strategies, investigator outreach plans, and enrollment forecasts.
- Provide feasibility inputs for governance reviews, program updates, and study team decisions.
- Collaborate with Site Management, Site Alliances, eTMF Oversight, and Site Contract Management functions.
- Support eTMF documentation planning, quality reviews, inspection readiness, and site contract and budget-related activities.
Requirements
- Bachelor’s degree required; a scientific, medical, or healthcare discipline is preferred.
- At least 5 years of experience in pharmaceutical, biotechnology, or CRO clinical drug development.
- At least 2 years of direct experience in feasibility, study planning, site identification, and enrollment forecasting.
- Experience supporting clinical operations across multiple programs or studies.
- Strong understanding of clinical trial design, clinical development phases, ICH-GCP, and the clinical development lifecycle.
- Strong analytical, communication, stakeholder management, Microsoft Office, and clinical systems skills.
Nice to have
- Experience with study startup, site management, eTMF, or contract management.
Culture & Benefits
- Work in a global, matrixed clinical development environment.
- Temporary assignments lasting 13 weeks or longer may include medical, dental, vision, and 401(k) benefits.
- Statutory sick pay is provided where required.
- Reasonable workplace accommodations are available for individuals with disabilities.
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