Remote Global Clinical Trial Lead

Praxis Precision Medicines, Inc.; Boston (MA); Teletrabalho; USD 168 000 - 188 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health insurance

401(k) with match

Stock incentives

Annual bonus

Paid time off

Resumo da oferta

Praxis Precision Medicines, Inc. is seeking a Senior Clinical Trial Manager to lead end-to-end management of domestic and international clinical studies, ensuring GCP compliance and timely delivery.

You will coordinate startup activities, budgets, TMF/document control, regulatory submissions, and data analysis support, collaborating across QA, Data Management, Biostats, Medical Writing, Safety, and Finance. Remote work with travel to the Boston area as needed.

Qualificações

• Bachelor’s degree in a scientific field required; advanced scientific degree a plus.
• 5+ years directly managing clinical trials in Sponsor or CRO setting.
• In-depth knowledge of clinical trial operations, ICH, GCP Guidelines and other applicable regulatory requirements.
• Experience directing members of clinical operations teams.
• Experience working across multiple functional areas (QA, Data Management, Biostats, Medical Writing, Safety, Clinical Supply, Finance).

Responsabilidades

• Manage study activities from protocol concept to clinical study report in compliance with GCP and international regulations.
• Manage strategic engagement with key collaborators.
• Set up and oversee TMF, startup progress, screening/enrollment, study invoices/payments, budgets.
• Key contributor to IRB/EC and regulatory submissions.
• Oversee TMF reviews for completeness and inspection readiness.
• Review documents to ensure adherence to SOPs and training guides.
• Identify and mitigate study risks and escalate as necessary.
• Direct initiatives to identify best practices and continuous improvement in clinical development.

Conhecimentos

Project management

Clinical operations

Regulatory knowledge

Team leadership

Communication

Formação académica

Bachelor’s degree in a scientific field

Advanced scientific degree

Descrição da oferta de emprego

Praxis Precision Medicines, Inc. is seeking a Senior Clinical Trial Manager to lead end-to-end management of domestic and international clinical studies, ensuring GCP compliance and timely delivery.

You will coordinate startup activities, budgets, TMF/document control, regulatory submissions, and data analysis support, collaborating across QA, Data Management, Biostats, Medical Writing, Safety, and Finance. Remote work with travel to the Boston area as needed.