Clinical Trial Manager/ Senior Manager

Edgewise Therapeutics, Inc.

New York (NY)

On-site

USD 120,000 - 180,000

Full time

5 days ago
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Job summary

Edgewise Therapeutics, Inc. seeks a Clinical Trial Manager or Senior Manager to oversee complex cardiovascular clinical studies with end-to-end operational management.

The role covers budget oversight, site coordination, vendor management, and strategic planning to support the company’s pipeline in heart disease and cardiometabolic conditions. Responsibilities include overseeing site selection, feasibility, activation, CRO/vendor oversight, and risk mitigation.

Qualifications

  • Clinical operations or trial management experience with complex, multi-site studies.
  • Expertise in budget development, vendor management, and contract negotiation.
  • Knowledge of clinical trial regulations, feasibility assessment, and site activation.
  • Experience with CRO/vendor oversight and performance management.
  • Proficiency in study planning, protocol deviations, and risk mitigation.
  • Strong organizational and cross-functional communication skills.

Responsibilities

  • Provide operational and strategic oversight for assigned clinical studies, including budget and timeline management.
  • Lead site selection, feasibility assessment, and activation activities in coordination with country insights and program strategy.
  • Oversee vendor, CRO, and strategic partner selection, contracting, and performance accountability.
  • Manage clinical research associate activities, monitoring plans, and site audit coordination with QA support.
  • Review protocol deviations, identify trends, and implement risk mitigation strategies across studies.

Skills

Budget development
Vendor management
Contract negotiation
Cross-functional communication
Site activation

Job description

Edgewise Therapeutics seeks a Clinical Trial Manager or Senior Manager to oversee complex cardiovascular clinical studies. The role involves end-to-end operational management of high-risk trials, including budget oversight, site coordination, vendor management, and strategic planning to support the company's pipeline in heart disease and cardiometabolic conditions.

Responsibilities
  • Provide operational and strategic oversight for assigned clinical studies, including budget and timeline management
  • Lead site selection, feasibility assessment, and activation activities in coordination with country insights and program strategy
  • Oversee vendor, CRO, and strategic partner selection, contracting, and performance accountability
  • Manage clinical research associate activities, monitoring plans, and site audit coordination with QA support
  • Review protocol deviations, identify trends, and implement risk mitigation strategies across studies
Requirements
  • Clinical operations or trial management experience with complex, multi-site studies
  • Expertise in budget development, vendor management, and contract negotiation
  • Knowledge of clinical trial regulations, feasibility assessment, and site activation
  • Experience with CRO/vendor oversight and performance management
  • Proficiency in study planning, protocol deviations, and risk mitigation
  • Strong organizational and cross-functional communication skills
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