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2 дня назад

Clinical Project Manager (Clinical Development)

120 000 - 165 000$
Формат работы
remote (только USA)
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Clinical Project Manager (Clinical Development) (clinical trials and regulatory compliance): Managing multi-site clinical trials across the full study lifecycle with an accent on protocol development, site and vendor coordination, and clinical documentation. Focus on coordinating cross-functional stakeholders, ensuring GCP and regulatory compliance, tracking study milestones and budgets, and resolving issues with external partners.

Location: United States of America - Remote

Salary: $120,000–$165,000 annually

Company

hirify.global develops healthcare solutions focused on improving healthcare delivery and saving and sustaining lives.

What you will do

  • Manage assigned multi-site clinical trials from protocol development and site selection through database lock and final clinical study report review.
  • Prepare or coordinate protocols, case report forms, informed consent documents, feasibility evaluations, and study plans.
  • Coordinate internal functions including Legal, Research and Development, Data Management, Medical Writing, Medical Affairs, Regulatory, Compliance, Training, and Marketing.
  • Manage clinical sites, investigators, research staff, contract research organizations, vendors, and institutional review boards.
  • Identify and assess sites, conduct investigator meetings and training, negotiate research agreements and study budgets, and track enrollment, adverse events, milestones, budgets, and forecasts.
  • Provide updates to senior management and escalate study issues as needed.

Requirements

  • Bachelor’s degree in clinical research, biostatistics, pharmacy, nursing, a related healthcare discipline, or equivalent experience.
  • 3–5 years of clinical research experience with increasing responsibility in trial coordination, clinical development, protocol management, or clinical project management.
  • Experience with multi-site clinical trials, external vendor management, and applicable regulatory requirements.
  • Working knowledge of Good Clinical Practice, ICH guidelines, FDA and EMA regulations, and clinical trial requirements.
  • Understanding of statistical principles, including ICH E9, clinical study design, endpoints, protocols, and regulatory documentation.
  • Strong project management skills covering scope, scheduling, budgeting, risk management, and KPI tracking.

Culture & Benefits

  • Remote work within the United States.
  • Medical and dental coverage beginning on the first day, plus life, accident, disability, and business travel insurance.
  • 401(k) retirement savings plan with employee contributions and company matching, employee stock purchase plan, and flexible spending accounts.
  • Paid holidays, 20–35 days of paid time off based on length of service, family and medical leave, and paid parental leave.
  • Educational assistance, commuting benefits, employee discounts, employee assistance, and childcare benefits.

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