2 дня назад
Sr. Manager, Clinical Management, Early Phase: Immunology/Auto-immune
150 034 - 224 250$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Sr. Manager, Clinical Management, Early Phase: Immunology/Auto-immune (Clinical Trials): Overseeing the planning, execution, and completion of early-phase immunology and autoimmune clinical studies with an accent on regulatory compliance, CRO and vendor management, and study budget control. Focus on managing complex First-in-Human SAD/MAD/POC trials, maintaining data integrity and TMF readiness, and coordinating cross-functional risk mitigation.
Location: Remote within the United States; travel up to 25% may be required.
Salary: $150,034–$224,250, plus incentive opportunity.
Company
Pharmaceutical Companies develops and commercializes pharmaceutical products, including therapies in immunology and autoimmune indications.
What you will do
- Oversee the planning, execution, and completion of early-phase clinical trials in compliance with regulations, ICH/GCP guidelines, and company SOPs.
- Contribute to clinical protocols, informed consent forms, and other critical study documents.
- Evaluate and oversee CROs, external service providers, central laboratories, IRBs, technology vendors, and investigative sites.
- Lead clinical teams and coordinate study activities across internal departments, CROs, vendors, and sites.
- Monitor study budgets, forecasts, resources, timelines, data integrity, and protocol compliance.
- Support inspection readiness, TMF quality, risk mitigation, standardization, and continuous improvement initiatives.
Requirements
- Ability to oversee complex First-in-Human SAD/MAD/POC trials, including basket trials, in immunology and autoimmune indications.
- Comprehensive knowledge of clinical operations, drug development, SOPs, GCP, ICH, and global regulatory requirements.
- At least 10 years of industry experience, including 7 years in clinical trial management.
- Bachelor’s degree or Registered Nurse qualification.
- Experience managing CROs, outsourcing activities, vendor statements of work, and clinical trial software such as eCRFs, IRT, and CTMS.
- Strong communication, organization, planning, analytical, problem-solving, and people-management skills.
Nice to have
- Previous supervisory experience.
- Experience with Microsoft Word, Excel, PowerPoint, and Outlook.
Culture & Benefits
- Full-time employment with flexible time off, paid holidays, and paid leave programs.
- Medical, dental, vision, and prescription drug coverage.
- Company-provided life, accidental death and dismemberment, and short- and long-term disability insurance.
- Tuition reimbursement and student loan assistance.
- Generous 401(k) matching program.
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