.Clinical Trial Manager - Sponsor Dedicated (Home-Based, Mexico)Updated: November 21, 2024Location: Mexico-Latin America - MEX-Home-BasedJob ID: 24006375Syneos 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.Discover what our 29,000 employees, across 110 countries already know:WORK HERE MATTERS EVERYWHEREWhy Syneos HealthWe are passionate about developing our people through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition; and total rewards program.We are committed to our Total Self culture – where you can authentically be yourself.We are continuously building the company we all want to work for and our customers want to work with.Job ResponsibilitiesResponsible 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, protocol execution risks, and risk mitigations related to the completion of the Risk Assessment and Categorization Tool (RACT).Reviews study scope of work, budget, and protocol content, ensuring the clinical project team is aware of contractual obligations.Uses prior clinical experience, operational data, metrics, and reports to identify risks to clinical trial management deliverables.Escalates risks to clinical trial management deliverables (timeline, quality, and budget) to the project manager.Employs strategic thinking and problem-solving skills to propose and implement risk mitigations.Participates and presents in key meetings such as Kick Off Meeting.Serves as an escalation point for communications with investigator site staff.Collaborates with functional leaders to coordinate delivery handoffs and meet expected study milestones.Responsible for development and ongoing maintenance of clinical study tools and templates.Coordinates initial and ongoing training to the study team regarding protocol specificities and clinical plans.Oversees resourcing allocations for CRAs and Central Monitors and identifies risks to delivery or quality.Ensures quality of clinical monitoring and site management deliverables within a project.Reviews project oversight dashboards and other clinical trial systems to oversee site and patient activities