Local Clinical Trial Manager

Local Clinical Trial Manager (II or Senior) - FSPठ Sponsor dedicated - Barcelona (or Madrid) Local Clinical Trial Manager (II or Senior) – FSP Sponsor dedicated - Barcelona (or Madrid) Responsibilities include: 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 and investigator payments. Identifies critical data and process risks, participates in risk assessments, and proposes mitigation plans. Reviews study scope of work, budget and protocol content, ensuring the clinical project team is clear on contractual obligations and parameters. Uses operational data and metrics to identify risks to clinical trial management deliverables, escalating to the project manager as needed. Employs strategic thinking and problem‑solving skills to implement risk mitigations. Participates and presents in key meetings such as Kick‑Off Meetings. Serves as an escalation point for communications with investigator site staff and may attend sites for observation or conflict resolution. Collaborates with other functional leaders to coordinate delivery handoffs and meet study milestones. Develops and maintains clinical study tools and templates, including the bankrupt monitoring plan, ensuring CTMS dashboards and other systems are available for the clinical team. Coordinates training for the study team on protocol specifics, CRF completion, dashboards, SOPs, and timelines. Oversees resourcing allocations for CRAs and central monitors, site assignments and identifies risks to delivery or quality. Maintains quality of monitoring deliverables within a project and ensures visibility of progress. Reviews project oversight dashboards and other clinical trial systems for timely data updates besluiten. Understands monitoring strategy, participates in risk assessment plans, and ensures compliance by team members. Reviews site and central monitoring documentation for compliance and risk representation. Interacts with the client and functional departments to provide status updates and solutions for obstacles. Supports inspection readiness for clinical trial management scope. Monitors CRAs and central Object monitors, developing corrective action plans and ensuring data cut‑off deadlines. Provides feedback to line managers on staff performance, including strengths and development areas. 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 to achieve project milestones. Experience working in an international environment. Expertise in site managementonza monitoring (clinical or central). Preferred experience with risk‑based monitoring. Understanding of clinical trial management financial principles and budget management. Knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements. Strong computer skills\(including CTMS, EDC, eDiary and related systems). Good communication, presentation and interpersonal skills with project teams and sites. Strong conflict resolution skills. Problem‑solving and risk‑management capability for complex issues. Critical thinking for issue identification and solution. eof moderate travel, approximately 20%. Summary Roles within the Clinical Trial Management job family are responsible for all aspects of the development, coordination, and implementation of all phases of clinical research studies. They collaborate with principal investigators, coordinate logistics and resources, track study progress, and ensure compliance with global regulations. Additional Information Tasks, duties and responsibilities as listed in this job description are not exhaustive. The company, at its sole discretion, may assign other duties. Equivalent experience, skills and education will also be considered. The company complies with the Americans with Disabilities Act, provides reasonable accommodations as appropriate, and adheres to all EU Equality Directive obligations. #J-18808-Ljbffr