[Hiring] Global Clinical Trial Manager II or Senior @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, including patient recruitment and investigator payments.
• Identifies critical data and process, protocol execution risks and risk mitigations related to the Risk Assessment and Categorization Tool (RACT).
• Reviews study scope of work, budget and protocol content; ensures clinical project team is aware of contractual obligations.
• Uses prior clinical experience and operational data to identify risks to clinical trial management deliverables.
• Escalates risks to project manager regarding timeline, quality, budget, and out-of-scope activities.
• Employs strategic thinking and problem-solving skills for 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 study milestones.
• Responsible for development and 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, site assignments, and study team conduct.
• Ensures quality of clinical monitoring, central monitoring and site management deliverables.
• Reviews project oversight dashboards and clinical trial systems to oversee site and patient activities.
• Understands monitoring strategy and participates in development of study risk assessment plan.
• Reviews content and quality of site and central monitoring documentation to ensure compliance.
• Interacts with clients and other functional departments regarding clinical monitoring activities.
• Demonstrates understanding of other functions' roles in achieving compliance and delivery.
• Oversees CRAs and Central Monitors, assesses compliance, and identifies emerging risks.
• Provides feedback to line managers on staff performance.

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.
• Understanding of clinical trial management financial principles and budget management.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Good computer skills.
• Good communication, presentation and interpersonal skills.
• Strong conflict resolution skills.
• Ability to apply problem-solving techniques to resolve complex issues.
• Demonstrates critical thinking to determine causes and solutions for issues.
• Moderate travel may be required, approximately 20%.

Benefits

• Career development and progression opportunities.
• Supportive and engaged line management.
• Technical and therapeutic area training.
• Peer recognition and total rewards program.
• Commitment to building an inclusive culture.

Company Description

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum.

• Worked with 94% of all Novel FDA Approved Drugs over the past 5 years.
• Collaborated on 95% of EMA Authorized Products.
• Conducted over 200 Studies across 73,000 Sites and 675,000+ Trial patients.