Senior Clinical Trial Manager — Remote with Boston Travel

Regulatory Jobs; Boston (MA); Híbrido; USD 168.000 - 188.000; Tempo integral

Benefícios oferecidos por esta vaga

Competitive benefits package

401(k) matching

Stock incentives

Discretionary bonus

Generous PTO and company-wide shutdown

Resumo da vaga

Praxis Precision Medicines is seeking a Senior Clinical Trial Manager to lead global clinical studies, coordinating initiation, execution and closeout while ensuring compliance with ICH and GCP. You will manage regulatory submissions, budgets, and TMF workflows, collaborating across QA, Data Management, Biostats, Medical Writing, and Safety teams.

The role allows remote work with travel to the Boston area as needed, and offers a comprehensive benefits package, including bonus potential and

Qualificações

• Bachelor’s degree in a scientific field is 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 in a matrix across multiple functional areas (Quality Assurance, Data Management, Biostats, Medical Writing, Safety, Clinical Supply, Finance).

Responsabilidades

• Manage study activities in the successful execution of clinical trials from protocol concept to clinical study report, complying with GCP and international regulations.
• Manage strategic engagement with key collaborators.
• Set up and oversee trial-related trackers (regulatory documents, TMF, startup progress, screening/enrollment, invoices/payments, budgets).
• Contribute to IRB/EC and regulatory submissions.
• Oversee TMF reviews for completeness and inspection readiness.
• Review documents for adherence to SOPs, work practices, training guides.
• Identify and mitigate study risks, escalating as necessary.
• Initiate and implement best practices and continuous improvement plans in clinical development.

Formação

Bachelor’s degree in a scientific field

Advanced scientific degree

Descrição da vaga

Praxis Precision Medicines is seeking a Senior Clinical Trial Manager to lead global clinical studies, coordinating initiation, execution and closeout while ensuring compliance with ICH and GCP. You will manage regulatory submissions, budgets, and TMF workflows, collaborating across QA, Data Management, Biostats, Medical Writing, and Safety teams.

The role allows remote work with travel to the Boston area as needed, and offers a comprehensive benefits package, including bonus potential and