Single Sponsor Global Clinical Trial Manager II - UK remote
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Overview
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. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to make Syneos Health easier to work with, and to make us easier to work for.
Job Responsibilities
* Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.
* Oversees site interactions post activation through site closeout, including patient recruitment, investigator payments and related activities.
* May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to the Risk Assessment and Categorization Tool (RACT).
* Reviews the study scope of work, budget and protocol content to ensure the clinical project team (CRAs/Central Monitors) is aware of contractual obligations and parameters.
* Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables.
* Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope.
* Employs strategic thinking and problem‑solving skills to propose and implement risk mitigations.
* Participates and presents in key meetings such as the Kick Off Meeting.
* Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators.
* Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones.
* Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan. Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team, overseeing user acceptance testing as needed.
* Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor SOPs, clinical plans and guidelines, data plans and timelines for the study.
* Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality.
* Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintains proper visibility of its progress by the use of approved systems and tracking tools.
* Reviews the project oversight dashboards and other clinical trial systems (CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS, Central Monitoring dashboards) to oversee site and patient activities, ensuring timely execution of operational aspects.
* Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan.
* Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports) to ensure they represent site management activities and conduct.
* Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities, providing status updates on deliverables and risks.
* Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations, supporting Inspection Readiness for clinical trial management scope.
* Oversees CRAs and Central Monitors assigned to the study, routinely assesses study-specific process and training compliance, and identifies emerging risks.
* Provides feedback to line managers on staff performance, including strengths and areas for development.
Qualifications
* Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
* Demonstrated ability to lead and align teams in the achievement of project milestones.
* Demonstrated capability of working in an international environment.
* Demonstrated expertise in site management and monitoring (clinical or central).
* Preferred experience with risk‑based monitoring.
* Demonstrates understanding of clinical trial management financial principles and budget management.
* Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
* Good computer skills.
* Good communication, presentation and interpersonal skills with project team and sites.
* Strong conflict resolution skills.
* Demonstrated ability to apply problem‑solving techniques to resolve complex issues, and a risk‑management approach to identifying and mitigating potential threats to a successful clinical research project.
* Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues.
* Moderate travel may be required, approximately 20%.
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.
The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. The Company also complies with relevant equality, diversity, and workplace safety laws in all operating countries.
Summary
Roles within the Clinical Trial Management job family are responsible for all aspects of the development, coordination, and implementation of Phase I‑IV clinical research studies. They collaborate with investigators, client teams, and clinic operations teams, plan logistics and resource usage, track study progress, maintain project milestones and budgets, and ensure compliance with global regulations.
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