обновлено 5 дней назад
Clinical Trial Project Manager
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Trial Project Manager (Clinical Research): Leading the setup, execution, and close-out of clinical trials with an accent on patient safety, data integrity, regulatory compliance, and cross-functional delivery. Focus on managing study risks, budgets, vendors, regulatory submissions, clinical trial systems, and stakeholder communication throughout the trial lifecycle.
Location: Remote within the United States; candidates must reside in a U.S. state where is authorized to hire. This role is not eligible for residents of California, Colorado, New York, Washington, New Jersey, Massachusetts, Illinois, Hawaii, or the District of Columbia. Travel may be required for business needs.
Company
provides end-to-end clinical trial delivery, home health services, expanded access programs, and market access consultancy for biopharmaceutical sponsors.
What you will do
- Lead the setup, execution, and close-out of clinical trials in compliance with SOPs, ICH GCP guidelines, and regulatory requirements.
- Manage operational delivery, study plans, timelines, performance metrics, documentation, eTMF, and CTMS systems.
- Lead cross-functional internal and external teams covering monitoring, site management, data management, pharmacovigilance, regulatory, supply, and medical writing.
- Act as the primary client contact and lead meetings covering project status, risks, timelines, deliverables, and issue resolution.
- Identify and mitigate risks, oversee corrective actions, and support audits, CAPAs, investigations, and regulatory submissions.
- Manage project budgets, vendors, invoices, site payments, and Clinical Trial Agreement requirements.
Requirements
- Bachelor’s degree; a health or science field is preferred.
- At least 5 years of experience as a Project Manager in clinical trials or clinical research.
- Demonstrated experience managing clinical trials from initiation through close-out.
- Strong working knowledge of ICH GCP guidelines and clinical trial processes.
- Ability to lead cross-functional teams, manage multiple priorities, and make sound decisions.
- Proficiency in Microsoft Office, with strong written and verbal communication skills.
Culture & Benefits
- Remote full-time work with a mission-driven focus on clinical research and patient outcomes.
- Medical, dental, and vision insurance, plus FSA and HSA options.
- Short- and long-term disability, life insurance, and a 401(k) safe harbor plan with company match.
- Paid vacation, holidays, sick time, volunteer time, and maternity and paternity leave.
- Initiatives supporting wellness, professional growth, development, and team relationships.
Hiring process
- Submit an English-language resume through the Careers Portal or LinkedIn Easy Apply.
- An Upwage AI screener may be used as part of the application process, followed by interviews with the team.
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