Senior Clinical Trials Lead — Remote

Praxis Precision Medicines; United States; Hybrid; USD 168,000 - 188,000; Full time

Benefits offered by this job

Discretionary quarterly bonus

Company-paid life insurance & AD&D

401(k) with company match

Stock incentives and ESPP

Generous PTO and holidays

Job summary

Praxis Precision Medicines is seeking a Senior Clinical Trial Manager to lead domestic and international trials, from initiation through closeout. The role requires oversight of study design, start-up, budget management, TMF, and regulatory submissions, with an emphasis on cost-effective, timely delivery.

You will coordinate cross-functional teams across QA, Data Management, Biostatistics, Medical Writing and Safety, ensuring quality and regulatory compliance while driving continuous improvement

Qualifications

• Bachelor’s degree in a scientific field required; advanced degree preferred.
• 5+ years directly managing clinical trials in Sponsor or CRO setting.
• Knowledge of clinical trial operations, ICH, GCP guidelines, and regulatory requirements.
• Experienced directing members of clinical operations teams.
• Experience working in a cross-functional environment (Quality, Data Management, Biostats, Medical Writing, Safety, Clinical Supply, Finance).

Responsibilities

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

Skills

Clinical trial management

GCP guidelines

Regulatory submissions

Cross-functional collaboration

Team leadership

Education

Bachelor’s degree in a scientific field

Advanced scientific degree

Tools

TMF management

Regulatory tracking tools

Job description

Praxis Precision Medicines is seeking a Senior Clinical Trial Manager to lead domestic and international trials, from initiation through closeout. The role requires oversight of study design, start-up, budget management, TMF, and regulatory submissions, with an emphasis on cost-effective, timely delivery.

You will coordinate cross-functional teams across QA, Data Management, Biostatistics, Medical Writing and Safety, ensuring quality and regulatory compliance while driving continuous improvement