Senior Clinical Trial Manager (CTM)

Praxis Precision Medicines, Inc.; Boston (MA); Remote; USD 168,000 - 188,000; Full time

Benefits offered by this job

Health insurance

401(k) with match

Stock incentives

Annual bonus

Paid time off

Job summary

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.

Qualifications

• 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).

Responsibilities

• 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.

Skills

Project management

Clinical operations

Regulatory knowledge

Team leadership

Communication

Education

Bachelor’s degree in a scientific field

Advanced scientific degree

Job description

Location: This position may be performed remotely with travel to the Boston area as needed.

Position Summary

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. This position requires both the knowledge and experience to work within established clinical trial paradigms while exploring and embracing new approaches to conducting research to support data aggregation and analysis to advance patient care. The Sr. CTM will participate on clinical project teams to achieve quality results in a cost-effective and timely manner. S/he will be a key team member to establish key practices and procedures for the clinical team.

Primary 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, project budgets, etc.
• 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 against study risks, escalating as necessary
• Direct initiatives to identify and implement best practices and continuous improvement plans in clinical development

Education And Professional Experience

• 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)

Other Essentials And Key Success Factors

• 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

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

Compensation & Benefits

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive. This includes 99% of the premium paid for medical, dental and vision plans. We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP. We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns. Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring. We aim high, collaborate hard, and produce results. Let’s achieve the impossible together!

Company Overview

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 and are exemplified by each and every one of our team members.

Diversity, Equity & Inclusion

Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.

Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.