[Hiring] Clinical Trial Manager I/II @Syneos Health Careers

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, ensuring the 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 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 functional leaders to coordinate delivery handoffs and meet 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 specifics 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.
• Reviews project oversight dashboards and clinical trial systems to ensure timely execution of operational aspects.
• Understands the monitoring strategy required for the study and participates in the development of the study risk assessment plan.
• Reviews the content and quality of site and central monitoring documentation.
• Interacts with clients 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, assessing study-specific process and training compliance.
• 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 the cause and appropriate solution in the identification of issues.
• Moderate travel may be required, approximately 20%.

Requirements

• Tasks, duties, and responsibilities as listed in this job description are not exhaustive.
• The Company may assign other tasks, duties, and job responsibilities at its sole discretion.
• Equivalent experience, skills, and/or education will also be considered.
• The Company will determine what constitutes as equivalent to the qualifications described above.
• Nothing contained herein should be construed to create an employment contract.
• The Company is committed to compliance with the Americans with Disabilities Act.

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.