[Hiring] Clinical Trial Manager II @Syneos Health Careers

Role Description

Clinical Trial Manager ll, Home based Romania or Hungary

Roles within the Clinical Trial Management job family are responsible for all aspects of the development, coordination, and implementation of Phase 1 through to Phase 4 clinical research studies at the organization's facilities. Responsibilities include:

• Collaborating with the principal investigator and liaising between research subjects, client teams, investigators, and clinic operations teams.
• Planning logistics and resource usage.
• Tracking study progress in alignment with project milestones, client deliverables, and budget.
• Following applicable regulations globally and by region.

Impact and Contribution:

• Includes executives as well as managers, supervisors, and team leads providing strategic vision and/or tactical direction across a discipline and/or broader organization.
• Majority of time spent overseeing area of responsibility, planning, prioritizing, and/or directing responsibilities of employees.
• Goals achieved through management of process, policy, and performance of direct and/or indirect reports.
• Supervises experienced support employees and/or entry individual contributors.
• Delivers operational results that have moderate impact on immediate achievement of results for the team.
• Broad job knowledge in an operational, administrative and/or specialized field, adapts new procedures, techniques, tools, etc.
• Understands basic management approaches such as work scheduling, prioritizing, coaching, and process execution.

Additional 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 and mitigations related to the completion of the Risk Assessment and Categorization Tool (RACT).
• Reviews study scope of work, budget, and protocol content, ensuring clinical project team awareness of contractual obligations.
• 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 specifics and clinical plans.
• Oversees resourcing allocations for CRAs and Central Monitors.
• Ensures quality of clinical monitoring, central monitoring, and site management deliverables.
• Reviews project oversight dashboards and other clinical trial systems to oversee site and patient activities.
• 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 the client and other functional departments related to clinical monitoring and site management activities.
• Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP, and country regulations.
• Oversees CRAs and Central Monitors assigned to the study and assesses study-specific process 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.
• 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.
• Good communication, presentation, and interpersonal skills among project team and with sites.
• 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.