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Clinical Study Site Manager
3 semanas atrás
Job Overview
Syneos Health is a leading biopharmaceutical solutions organization that accelerates customer success by translating unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
About the Job
We are seeking a Clinical Study Site Manager to join our team. This role will be responsible for performing site qualification, site initiation, interim monitoring, site management activities and close-out visits ensuring regulatory compliance.
Key Responsibilities
- Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory compliance.
- Evaluates overall performance of site and site staff and provides 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.
- Protects the confidentiality of each subject/patient and assesses factors that might affect their safety and clinical data integrity at an investigator/physician site.
- Assesses site processes, conducts source document review, verifies required clinical data entered in the case report form and applies query resolution techniques remotely and on site.
- May perform investigational product inventory, reconciliation and reviews storage and security.
- Routinely reviews the Investigator Site File for accuracy, timeliness and completeness and reconciles contents with the Trial Master File.
- Documents activities via confirmation letters, follow-up letters, trip reports, communication logs and other required project documents.
- 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.
- Excellent communication, presentation and interpersonal skills.
- Ability to manage required travel of up to 75% on a regular basis.
- Experience in Neurology, Immuno-Inflammation (Respiratory/Dermatology), Rare Disease, Vaccines or related field.
Estimated Salary Range: $60,000 - $90,000 per year, depending on experience.
About Syneos Health
Syneos Health is a leading integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
