Senior Clinical Trial Manager (CTM)
New
J
JobgetherClinical research
This is a remote opportunity within the United StatesFull-TimeSenior
Salary$168,000–$188,000 USD
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Job Details
- Experience
- At least 5 years of direct clinical trial management experience in a sponsor or Contract Research Organization (CRO) setting.
- Required Skills
- Project ManagementRisk Management
Requirements
- Bachelor's degree in a scientific field; an advanced scientific degree is a plus.
- At least 5 years of direct clinical trial management experience in a sponsor or CRO setting.
- In-depth knowledge of clinical trial operations, ICH guidelines, GCP, and applicable regulatory requirements.
- Experience directing or coordinating clinical operations team members.
- Ability to collaborate across functional areas and manage complex clinical projects.
- Strong project management, organizational, and time-management skills, with attention to detail.
- Ability to identify risks, solve problems, and make sound decisions under time pressure.
- Ability to work autonomously and contribute effectively to a collaborative team.
- Excellent written and verbal communication skills and ability to build internal and external relationships.
- Willingness and flexibility to travel to the Boston area as needed.
Responsibilities
- Lead the initiation, execution, and closeout of clinical trials in compliance with GCP and international regulatory requirements.
- Contribute to study concept development, protocol design, feasibility assessments, and study start-up.
- Manage relationships and engagement with collaborators and external stakeholders.
- Maintain trial trackers for regulatory documentation, TMFs, start-up progress, screening and enrollment, invoices, payments, and project budgets.
- Contribute to IRB, Ethics Committee, and other regulatory submissions.
- Oversee TMF reviews and verify documentation is complete, accurate, and inspection-ready.
- Review clinical documentation for compliance with Clinical Operations standards, quality requirements, SOPs, and training guidelines.
- Identify, assess, and mitigate study risks, escalating issues when necessary.
- Coordinate with Quality Assurance, Data Management, Biostatistics, Medical Writing, Safety, Clinical Supply, and Finance.
- Support data exchange, analysis, and interpretation, and drive best practices and continuous improvement.
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