2 дня назад
Clinical Project Manager (Clinical Development)
120 000 - 165 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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
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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