Senior Clinical Trial Manager (CTM)

Senior Clinical Trial Manager (CTM)

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

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.

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

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)

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 - $188,000 USD

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.