19 ene
Syneos Health
Xico
Clinical Trial Manager Full-Service with experience in USA - Home Based LATAMUpdated: January 14, 2025
Location: Mexico-Latin America - MEX-Home-Based
Job ID:25001160
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.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.
We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
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 and investigator payments.Identifies critical data and process risks related to protocol execution.Reviews the study scope of work, budget and protocol content, ensuring awareness of contractual obligations.Uses prior clinical experience to identify risks to clinical trial management deliverables.Escalates risks to the project manager regarding timeline, quality,
and budget.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 other functional leaders to coordinate delivery handoffs and meet expected study milestones.Responsible for development and maintenance of clinical study tools and templates.Coordinates training to the study team regarding protocol specifics and clinical plans.Oversees resource allocations for CRAs and Central Monitors.Ensures quality of clinical monitoring and site management deliverables.Reviews project oversight dashboards and clinical trial systems.Participates in the development of the study risk assessment plan.Reviews site and central monitoring documentation for compliance.Interacts with clients and other departments regarding clinical monitoring activities.Demonstrates understanding of other functions' roles in achieving compliance.Oversees CRAs and Central Monitors and assesses compliance.Provides feedback to line managers on staff performance.May be assigned to larger, more complex trials.Qualifications What we're looking for
• 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 capability of working in an international environment
• Demonstrated expertise in site management and monitoring
• Preferred experience with risk-based monitoring
• Demonstrates understanding of clinical trial management financial principles
• Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements
• Must demonstrate good computer skills
• Good communication, presentation and interpersonal skills
• Strong conflict resolution skills
• Demonstrated ability to apply problem-solving techniques
• Demonstrates critical thinking to determine causes and solutions
• Moderate travel may be required, approximately 20%
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