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 puts the customer and the patient at the center of everything we do, and we continuously strive to simplify and streamline our work to be easier to work with for both our clients and our teams.

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 potential patient recruitment, investigator payments or other related activities.
• May identify 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 (CRAs/Central Monitors) 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 to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities or requests outside contracted scope.
• Employs strategic thinking and problem-solving skills to propose and implement risk mitigations.
• Participates in key meetings such as Kick Off Meeting and presents as required.
• Acts as an escalation point for communications with investigator site staff and may interact on the phone or in person with principal investigators and site staff; may accompany CRA team members to sites as needed.
• Collaborates with Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet milestones such as site activation targets, enrollment targets and database lock timelines.
• Reviews and provides feedback on related functional plans (e.g., Data Management Plan, Communication Plan).
• Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan; ensures CTMS, dashboards and other systems are set up and available for the clinical team; oversees user acceptance testing (UAT) as needed and ensures access/audit trails as required.
• Coordinates initial and ongoing training to the study team regarding protocol specifics, CRF completion, dashboards, Sponsor SOPs, clinical plans and guidelines, data plans and timelines.
• Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team conduct, and identifies risks to delivery or quality.
• Ensures quality of clinical monitoring, central monitoring and site management deliverables within a project and maintains visibility of progress using approved systems/tools.
• Reviews project oversight dashboards and systems (CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS, Central Monitoring dashboards) to oversee site and patient activities and ensure data reflects timely execution of visits/calls and timelines.
• Understands the monitoring strategy for the study and, where required, participates in developing the study risk assessment plan. Ensures team understanding and compliance with monitoring strategy, CMP/SMP and risk plans.
• Reviews content and quality of site and central monitoring documentation (site monitoring calls/reports, site letters, central monitoring reports) to ensure they reflect site management activities and appropriately convey risks to protocol/GCP compliance, trial conduct, patient safety or data integrity; documents revisions and approvals in CTMS.
• Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management; provides status updates on deliverables and risks and offers solutions to obstacles in protocol execution and site management.
• Shows understanding of other functions’ roles (data management, study start up, patient recruitment, medical monitoring, pharmacovigilance, QA) and supports inspection readiness for clinical trial management scope.
• Oversees CRAs and Central Monitors, assesses process/training compliance and supports corrective action plans at site/study level; supports and completes activities to achieve data cut and lock deadlines.
• Provides feedback to line managers on staff performance and may be assigned to larger, more complex trials.

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 to achieve 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 regulatory requirements.
• Good computer skills.
• Strong communication, presentation and interpersonal skills with project teams and sites.
• Strong conflict resolution skills.
• Ability to apply problem-solving techniques to resolve complex issues and use risk management to identify and mitigate threats to successful conduct of a clinical study.
• Demonstrates critical thinking to determine causes and appropriate solutions.
• Moderate travel may be required, approximately 20%.

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks at its sole discretion. Equivalent experience, skills, and/or education will be considered. The Company will determine what constitutes equivalence to the qualifications described. Nothing herein should be construed as a contract. The Company complies with applicable laws and is committed to an accessible and inclusive workplace.