[Hiring] Senior Clinical Trial Manager @Praxis Precision Medicines, Inc.

Role Description

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.

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

Requirements

• 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

Benefits

• 99% of the premium paid for medical, dental and vision plans
• Company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize coverage
• Dollar-for-dollar match up to 6% on eligible 401(k) contributions
• Long-term stock incentives and ESPP
• Discretionary quarterly bonus
• Flexible wellness benefit
• Generous PTO, paid holidays and company-wide shutdowns

Company Description

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.

• Core Values: Trust, Ownership, Curiosity, and Results
• Commitment to diversity, equity, and inclusion