Updated: Yesterday Location: CHE-Remote Job ID: 25107706
Syneos Health® is a leading fully 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.
Job 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.
Uses judgment and experience to evaluate overall performance of site and site staff, provides recommendations, and communicates/escalates serious issues to the project team, developing action plans.
Verifies informed consent processes, protects confidentiality, and assesses factors that may affect subject safety and data integrity at investigator sites.
Assesses site processes, conducts source document review, verifies clinical data entered in the case report form (CRF) is accurate and complete, and applies query resolution techniques.
Supports investigational product inventory, reconciliation, storage, and security; ensures proper dispensation and handling of IP.
Reviews the Investigator Site File (ISF) and reconciles it with the Trial Master File (TMF), ensuring archiving requirements are met.
Documents activities via confirmation letters, follow‑up letters, trip reports, and communication logs as per SOPs and the monitoring plan.
Manages site‑level activities and communications to meet project objectives, deliverables, and timelines, adapting to changing priorities.
Acts as primary liaison with study site personnel and collaborates with Central Monitoring Associates.
Prepares for and attends investigator meetings, sponsor face‑to‑face meetings, and global clinical monitoring/project staff meetings.
Provides guidance toward audit readiness and supports preparation for audits and required follow‑up actions.
Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance and completes assigned training as required.
Qualifications
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.
Previous monitoring experience.
Excellent computer skills and ability to embrace new technologies.
Excellent communication, presentation and interpersonal skills.
Fluency in German; proficiency in English; French an asset.
Ability to manage required travel for monitoring.
We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.
Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, please contact us at jobs@syneoshealth.com.
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