Clinical Trial Manager - Sponsor dedicated (Remote, with travel))

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

We are 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. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.

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 and investigator payments.
• 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.
• Collaborates with other functional leaders to coordinate delivery handoffs and meet expected study milestones.
• Reviews and provides feedback on other functional plans as they relate to the clinical trial management activities.
• Responsible for development and ongoing maintenance of clinical study tools and templates.
• Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team.
• 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 members' conduct.
• Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project.
• Reviews the 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.
• Is accountable for their assigned clinical team members' understanding, ongoing compliance and delivery according to the stated monitoring strategy.
• Reviews the content and quality of site and central monitoring documentation.
• Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities.
• Provides status updates on the clinical deliverables and risks to clients, project management and leadership.
• Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations.
• Supports Inspection Readiness for clinical trial management scope.
• Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance.
• May develop and support execution of corrective action plans at site and study level.
• 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.
• Preferred experience with risk-based monitoring.
• 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.
• Moderate travel may be required, approximately 20%.

At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. We also encourage you to join our Talent Network to stay connected to additional career opportunities.