CTM - Future Roles (UK)
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. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®.
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 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; immediately communicates/escalates serious issues to the project team.
* Verifies that 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 such as protocol deviation/violations and pharmacovigilance issues.
* For the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes, conducts Source Document Review, and verifies clinical data entry in the case report form (CRF) is accurate and complete.
* Applies query resolution techniques remotely and on site, driving query resolution to closure within agreed timelines.
* May perform investigational product (IP) inventory, reconciliation and reviews storage and security.
* Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness and reconciles contents with the Trial Master File (TMF).
* Documents activities via confirmation letters, follow-up letters, trip reports, and communication logs.
* Manages site-level activities and communication to ensure project objectives, budgets, and timelines are met.
* Provides guidance at the site and project level towards audit readiness standards.
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.
* 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.
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