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 or related activities.

Identify critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT).

Review the study scope of work, budget and protocol content; ensure the clinical project team (CRAs/CeMs) is aware of contractual obligations and parameters.

Use prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables; escalate risks (timeline, quality, budget) and out-of-scope activities to the project manager.

Apply strategic thinking and problem-solving to propose and implement risk mitigations.

Participate and present in key meetings such as Kick Off Meetings.

Act as escalation point for communications with investigator site staff and interact with principal investigators or site staff as needed.

Collaborate with Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet study milestones (site activation targets, enrollment targets, database lock timelines).

Review and provide feedback on functional plans (e.g., Data Management Plan, Communication Plan) related to clinical trial management activities.

Develop and maintain clinical study tools and templates, including the Clinical Monitoring Plan; ensure CTMS and dashboards are set up and available for the clinical team, including user acceptance testing as needed.

Ensure access and audit trail reviews are conducted as required.

Coordinate initial and ongoing training to the study team regarding protocol specifics,



CRF completion, dashboards, SOPs, clinical plans and timelines.

Oversee resourcing allocations for CRAs and Central Monitors, site assignments and study team conduct; identify risks to delivery or quality.

Maintain quality of monitoring deliverables and visibility of progress using approved systems or tracking tools.

Review project oversight dashboards and systems (CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS, Central Monitoring dashboards) to oversee site and patient activities and ensure data reflects timely execution of required visits/calls, duration and frequency per plan.

Understand monitoring strategy; participate in development of the study risk assessment plan where required.

Ensure the assigned clinical team understands and complies with the monitoring strategy, CMP/SMP and risk plans.

Review site and central monitoring documentation (site monitoring calls, visit reports, letters, central monitoring reports, pertinent correspondence) to reflect site management activities and convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity.

Document requested revisions and approvals in CTMS; ensure deliverables meet sponsor specifications and deadlines.

Interact with client and other functional departments related to monitoring activities and deliverables; provide status updates on deliverables and risks as per agreements.





Provide solutions for obstacles in protocol execution and site management; collaborate with other functions to achieve compliance and delivery per protocol, SOPs, ICH GCP and country regulations (may involve data management, study start up, patient recruitment, medical monitoring, pharmacovigilance and QA).

Support Inspection Readiness for the clinical trial management scope.

Oversee CRAs and Central Monitors; assess process and training compliance, CMP compliance, and identify risks; develop and support corrective action plans at site and study level.

Support and complete activities to achieve data cut and lock deadlines; provide feedback to line managers on staff performance.

May coordinate larger, more complex trials or a team of CTMs across a portfolio; may coach and mentor CTMs on delivery, risk evaluation and action implementation.

Qualifications Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.

Proven vendor management experience; integral study management experience;

experience in Oncology clinical trials.

Strong experience reviewing and overseeing study plans and related documentation.

Demonstrated ability to lead and align teams to achieve project milestones;

experience working in an international environment.

Demonstrated expertise in site management and 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 other applicable regulatory requirements.

Strong computer skills and conflict resolution abilities; demonstrated problem-solving with a risk-management approach.

Demonstrates critical thinking to identify issues and determine appropriate solutions.

Moderate travel may be required, approximately 20%.

📌 Sr CTM - Home Based in SPAIN. FSP. Oncology experience is required.. (Madrid)
🏢 JobFlurry
📍 Madrid