Senior Clinical Trial Manager managing global Phase 3 clinical trials for oncology at Verastem Oncology. Overseeing vendor management, budget adherence, and regulatory compliance throughout the project lifecycle.
About the role
- Clinical Trial Manager ensuring regulatory compliance and site performance for clinical studies at Syneos Health. Assessing site operations and supporting project team collaboration for successful outcomes.
Responsibilities
- Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance.
- Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions.
- Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
- Supports subject/patient recruitment, retention and awareness strategies.
- Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
Requirements
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Must demonstrate good computer skills and be able to embrace new technologies
- Excellent communication, presentation and interpersonal skills
- Ability to manage required travel of up to 75% on a regular basis.
Benefits
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Diversity of thoughts, backgrounds, cultures, and perspectives.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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