Sponsor Dedicated Local Clinical Trial Manager Ii

hace 2 días

Madrid, España Syneos Health, Inc. A tiempo completo

.Sponsor Dedicated Local Clinical Trial Manager II - Home Based in Madrid or Barcelona area Updated: December 23, 2024Location: Spain-Europe - ESP-Home-Based (Madrid)Job ID: 24006920 Sponsor Dedicated Local Clinical Trial Manager II - Home Based Madrid or Barcelona area Previous CTM experience is required.
Experience in Neurology, Rare disease, or Dermato/immuno inflammation diseases is preferred.
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 not only make Syneos Health easier to work with but 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, or other related activities.
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.
Employs strategic thinking and problem-solving skills to propose and implement risk mitigations.
Participates and presents in key meetings such as Kick Off Meeting.
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.
Ensures quality of the clinical monitoring, central monitoring, and site management deliverables within a project.
Reviews the project oversight dashboards and other clinical trial systems to oversee site and patient activities.
Understands the monitoring strategy required for the study and participates in the development of the study risk assessment plan.
Reviews the content and quality of site and central monitoring documentation to ensure compliance.
Interacts with the client and other functional departments related to clinical monitoring, central monitoring, and site management activities

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