Jobs in Gniezno, Poland

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 centers the customer and patient experience, with a focus on simplifying and streamlining our work. Whether you join in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers to accelerate the delivery of therapies and change lives.

Discover what our 29,000 employees across 110 countries already know: WORK HERE MATTERS EVERYWHERE

We are committed to developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards. We foster a Total Self culture where everyone can authentically be themselves and belong. We work to create a diverse, inclusive environment where new ideas come from diverse backgrounds and perspectives.

• 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. This may include 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).
• Review the study scope of work, budget and protocol content and ensure the clinical project team (CRAs/CeMs) is aware of contractual obligations and parameters. Use prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables. Escalate to the project manager any risks to deliverables (timeline, quality and budget) and any activities/requests out of contracted scope.
• Employ strategic thinking and problem-solving to propose and implement risk mitigations. Participate and present in key meetings such as Kick Off Meeting.
• Serve as escalation point for communication with investigator site staff and may interact with principal investigators or site staff. May accompany CRA team members to sites for observation or conflict resolution.
• Collaborate with Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet milestones (site activation, enrollment, database lock timelines). Review and provide feedback on functional plans related to trial management.
• Develop and maintain clinical study tools and templates, including the Clinical Monitoring Plan. Ensure CTMS and dashboards are set up and available; oversee user acceptance testing and conduct audit trails as required.
• Coordinate training to the study team on protocol specifics, CRF completion, dashboards, SOPs, data plans and timelines.
• Oversee resourcing for CRAs and Central Monitors, site assignments and conduct to identify risks to delivery or quality. Maintain visibility of progress using approved systems/tools.
• Review project dashboards and other trial systems (CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS, Central Monitoring dashboards) to oversee site and patient activities and ensure data is updated for timely execution of operational aspects.
• Understand the monitoring strategy and participate in developing the study risk assessment plan. Ensure team compliance with the monitoring strategy, CMP/SMP and risk plans.
• Review site/central monitoring documentation to ensure it conveys risks to protocol/GCP compliance, trial conduct, patient safety or data integrity; document revisions in CTMS and meet delivery deadlines.
• Interact with client and other functions regarding monitoring activities; provide status updates and solutions for obstacles in protocol execution and site management.
• Demonstrate understanding of other functions’ roles to achieve compliance and delivery; support inspection readiness for clinical trial management scope.
• Oversee CRAs and Central Monitors; assess process/training compliance; identify risks; develop corrective action plans; support data cut and lock deadlines.
• Provide feedback to line managers on staff performance; may coordinate activities for a team of CTMs across a portfolio; may coach CTMs on clinical delivery and risk management.

• 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; experience in international environments
• 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 and strong conflict resolution abilities
• Demonstrated ability to apply problem-solving techniques and risk management to mitigate threats to successful conduct of a clinical project
• Critical thinking to identify issues and determine 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 discretion. We comply with applicable laws and provide accommodations as needed during the application process.

Roles within the Clinical Trial Management job family are responsible for the development, coordination, and implementation of Phase 1 clinical studies. They collaborate with investigators, client teams, and operations staff, plan logistics, track progress, and ensure compliance with regulations globally and regionally.