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 at Syneos Health performing site management and monitoring across clinical trials. Ensuring compliance with regulations while supporting site staff in operational activities.
Responsibilities
- Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely)
- 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
- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient
- Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site
- Conducts Source Document Review of appropriate site source documents and medical records
- Verifies compliance with electronic data capture requirements
- Supports subject/patient recruitment, retention and awareness strategies
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
- supportive and engaged line management
- technical and therapeutic area training
- peer recognition
- total rewards program
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
Clinical Scientist Director supporting early phase clinical development at AMGEN. Collaborating to translate scientific strategy into actionable execution across clinical trials.
Clinical Scientist Director supporting late - phase clinical development by translating scientific and clinical strategy into actionable execution. Overseeing clinical trials and ensuring data integrity while collaborating with cross - functional teams.
Clinical Research Program Manager leading clinical research activities at Caris Life Sciences. Focusing on trial enrollment, project management, and multi - department collaboration.
Analyst managing documentation for clinical studies at Artha. Engaging with regulatory compliance and supporting research documentation processes.
Senior Manager overseeing clinical studies and drug development programs at Regeneron. Collaborating with cross - functional teams to ensure data integrity and compliance with clinical guidelines.
Clinical Research Data Coordinator supporting clinical data management at Winship Cancer Institute. Assisting in clinical trials, maintaining records, and ensuring regulatory compliance.
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.
Clinical Trial Manager responsible for site management oversight and ensuring compliance with regulations. Collaborating with teams to achieve clinical trial objectives while managing risks.
Clinical Research Data Coordinator responsible for managing data activities in clinical trials at Winship Cancer Institute. Collaborating with teams to ensure data accuracy and compliance.