Description
Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success.
The Clinical Trial Manager II - Mexico Remote role is part of the Clinical Solutions team, which acts with a drug development mindset to understand customer needs and represent those in the solutions they shape.
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 and 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 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 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.
- Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members.
- Collaborates with other functional leaders to coordinate delivery handoffs and meet expected study milestones.
- Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan.
- Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion and Sponsor Standard Operating Procedures (SOPs).
- Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct.
- Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project.
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 in the achievement of project milestones.
- Demonstrated capability of working in an international environment.
- Demonstrated expertise in site management and monitoring (clinical or central).
- Preferred experience with risk-based monitoring.
- Demonstrates understanding of clinical trial management financial principles and budget management.
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
- Must demonstrate good computer skills.
- Strong conflict resolution skills.
- Demonstrated ability to apply problem solving techniques to resolve complex issues and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project.
Additional Information
- Moderate travel may be required, approximately 20%.