Senior Clinical Trial Manager (CTM)

About the role

This role will be responsible for project management in the initiation, execution, and close-out of domestic and international clinical studies, including study concept and design, feasibility assessments, study start-up, contract and budget oversight, data exchange, and support of data analysis and interpretation. The Senior Clinical Trial Manager will work within established clinical trial paradigms while exploring and embracing new approaches to conducting research to advance patient care. This position requires participation on clinical project teams to achieve quality results in a cost-effective and timely manner and will be a key team member in establishing key practices and procedures for the clinical team.

Responsibilities

• Manage study activities in the successful execution of clinical trials from protocol concept to clinical study report, complying with Good Clinical Practice (GCP) guidelines and international regulations.
• Manage strategic engagement with key collaborators.
• Set up and oversee clinical trial-related trackers such as regulatory documents, trial master file (TMF), startup progress, screening/enrollment, study invoices/payments, and project budgets.
• Key contributor to IRB/EC and regulatory submissions.
• Oversee TMF reviews to ensure completeness and inspection readiness.
• Regularly review documents to ensure adherence to Clinical Operations and/or project-specific quality requirements (e.g., SOPs, work practices, training guides).
• Identify and mitigate study risks, escalating as necessary.
• Direct initiatives to identify and implement best practices and continuous improvement plans in clinical development.

Requirements

• 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 in a team across multiple functional areas (e.g., Quality Assurance, Data Management, Biostats, Medical Writing, Safety, Clinical Supply, Finance).

Skills

• Intellectual curiosity, innovation, and creative problem-solving with an entrepreneurial spirit.
• Ability to think critically in fast-paced projects with a keen sense of urgency and demonstrated ability to problem-solve.
• Self-motivated and able to work autonomously, as well as a member of a collaborative team.
• Highly organized and detail-oriented with a passion to deliver quality results.
• Strong verbal and written communication skills with an ability to build relationships internally and externally.
• Highest levels of professionalism, confidence, personal values, and ethical standards.

Pay

Annualized Base Salary: $168,000 USD - $188,000 USD

Benefits

• 99% of the premium paid for medical, dental, and vision plans.
• Company-paid life insurance, AD&D, and disability benefits.
• Voluntary plans to personalize your coverage.
• 401(k) matching dollar-for-dollar up to 6% on eligible contributions.
• Long-term stock incentives and Employee Stock Purchase Plan (ESPP).
• Discretionary quarterly bonus.
• Extremely flexible wellness benefit.
• Generous PTO, paid holidays, and company-wide shutdowns.

About the company

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis, we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high-impact medicines for patients and families affected by and living with complex brain disorders. Our core values of Trust, Ownership, Curiosity, and Results are foundational to every aspect of our business.