Praxis Precision Medicines, Inc.
Senior Clinical Trial Manager (CTM)
United States - Remote · Senior
Sponsorship not specifiedDetected 104 days ago
GCPData AnalysisProject ManagementClinical TrialsResearchProblem SolvingGxP
About the role
- 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.
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
- Direct initiatives to identify and implement best practices and continuous improvement plans in clinical development
Requirements
- Ability to think critically in fast-paced projects with a keen
Nice to have
- Key contributor to IRB/EC and regulatory submissions
- Oversee TMF reviews to ensure completeness and inspection readiness
- Identify and mitigate against study risks, escalating as necessary
- 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
Visa & Work Authorization
- 5+ years directly managing clinical trials in Sponsor or CRO setting
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