Praxis Precision Medicines, Inc.

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

This listing is sourced directly from Praxis Precision Medicines, Inc.'s careers page and normalized into a canonical job model.