Clinical Site Manager
3 weeks ago
Syneos Health, Inc. Overview
At Syneos Health, we accelerate customer success by translating unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
We believe in building a diverse, inclusive and authentic workplace where everyone feels valued and empowered to contribute their best work.
About the Job
We are seeking an experienced Clinical Site Manager to join our team in Denmark-Europe. As a Clinical Site Manager, you will be responsible for performing site qualification, site initiation, interim monitoring, site management activities and close-out visits, ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
You will verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. You will also assess factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
The salary for this role is approximately $85,000 per year, depending on your qualifications and experience.
Key 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 Pharmacoepidemiology Practice (GPP) and protocol compliance.
- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.
- Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
- Conducts source document review of appropriate site source documents and medical records.
- Verifies required clinical data entered in the case report form (CRF) is accurate and complete.
- Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
- Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture.
- Verifies site compliance with electronic data capture requirements.
- Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
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.
- Able to manage required travel of up to 75% on a regular basis.
Benefits
We offer a comprehensive benefits package including health insurance, retirement savings plan, paid time off, and professional development opportunities.
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