[Hiring] Global Senior Clinical Trial Manager @Syneos Health

Role Description

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. This may include 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.
• Ensures the clinical project team (CRAs/CeMs) is aware of contractual obligations and parameters.
• Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables.
• Escalates risks to project manager regarding clinical trial management deliverables (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 ongoing maintenance of clinical study tools and templates.
• Coordinates initial and ongoing training to the study team regarding protocol specificities.
• Oversees resourcing allocations for CRAs and Central Monitors.
• Reviews project oversight dashboards and other clinical trial systems.
• Understands the monitoring strategy required for the study.
• Reviews the content and quality of site and central monitoring documentation.
• Interacts with the client and other functional departments related to clinical monitoring activities.
• Demonstrates understanding of other functions' roles in achieving compliance and delivery.
• Oversees CRAs and Central Monitors assigned to the study.
• Provides feedback to line managers on staff performance.
• May be assigned to larger, more complex trials or coordinate clinical activities for a team of CTMs.
• May coach and mentor CTMs regarding functional clinical delivery.

Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.
• Proven vendor management experience.
• Global study management experience.
• Experience in Oncology clinical trials.
• Strong experience reviewing and overseeing study plans and study-related documentation.
• 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.
• Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues.
• Moderate travel may be required, approximately 20%.

Benefits

• 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.
• Commitment to building an inclusive culture.
• Opportunity to shape solutions that impact lives.
• Collaborative environment with smart colleagues.