Clinical Trial Manager II.

Clinical Trial

Manager II.

Syneos

Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. supportive and engaged line management; technical and therapeutic area training; Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.

May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT). Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/CeMs) is aware of the 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. Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines.

Data Management

Plan, Communication Plan) as they relate to the clinical trial management activities. 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, including overseeing user acceptance testing (UAT) as needed.

Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (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 maintain proper visibility of its progress by the use of approved systems and / or tracking tools.





Reviews the project oversight dashboards and other clinical trial systems (e.g.

Clinical Trial Management

System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs), Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) according to plan. Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan. Is accountable for their assigned clinical team members' understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans.

Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity. Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables. Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements.

Provides solutions for obstacles in protocol execution and site management. This may include data management, study start up, patient recruitment, medical monitoring, pharmacovigilance and Quality Assurance (QA).

Supports Inspection

Readiness for clinical trial management scope. Oversees CRAs and Central Monitors assigned to the study and routinely assesses study‑specific process and training compliance, CMP compliance, and identifies emerging risks. Supports and completes activities to achieve data cut and lock deadlines.

Provides feedback to line managers on staff performance including strengths as well as areas for development. 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 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 Good communication, presentation and interpersonal skills among project team and with sites Demonstrated ability to apply problem solving techniques to resolve complex issues, and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project. Get to know Syneos Health Learn more about Syneos Health.

Further, nothing contained herein should be construed to create an employment contract. 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. Roles within the Clinical Trial Management job family are responsible for all aspects of the development, coordination, and implementation of Phase 1 clinical research studies at the organization's facilities.

Collaborates with the principal investigator, liaisons between research subjects, client teams, investigators, and clinic operations teams, and plans logistics and resource usage. Tracks study progress in alignment with project milestones, client deliverables, and budget, and follows applicable regulations globally and by region. The majority of time is spent overseeing their area of responsibility, planning, prioritizing, and/or directing the responsibilities of employees.

Goal are achieved through management of process, policy, and performance of direct and/or indirect reports. Delivers operational results that have moderate impact on the immediate achievement of results for the team. Understands basic management approaches such as work scheduling, prioritizing, coaching and process execution.

We work hard, and smart, all in the name of getting much‑needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world.

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. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. #

📌 Manager, Clinical Trial Management (Madrid)
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📍 Madrid