Clinical Trial Manager I - Hybrid (Sponsor-Dedicated)

Syneos Health, Inc.; Warszawa; On-site; PLN 70,000 - 110,000; Full time

Job summary

Syneos Health in Warsaw, Poland seeks a Clinical Trial Manager I (Sponsor-dedicated) for a hybrid role. You will oversee site management, clinical monitoring, and central monitoring deliverables with focus on patient safety, GCP compliance, and data integrity.

You will coordinate with CRAs, central monitors, and cross‑functional teams, manage study timelines, budgets, and risk mitigation, and ensure tools and dashboards are ready for use.

Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
• Ability to lead and align teams in achieving project milestones.
• Min. 1 year experience as CTM or similar.
• Capable of working in an international environment.
• Previous clinical trial experience in site management.
• Preferred experience with risk-based monitoring and clinical or central monitoring.
• Familiar with financial principles and budget management practices.
• Knowledge of GCP/ICH and regulatory requirements.
• Good computer skills.
• Strong communication, presentation and interpersonal skills with project teams and sites.
• Basic conflict resolution skills.
• Ability to apply problem solving techniques to resolve complex issues and manage risks.
• Demonstrates critical thinking for issue resolution.
• Moderate travel may be required, ~20%.

Responsibilities

• Oversee site management oversight, clinical monitoring and central monitoring with focus on patient safety, protocol/GCP/regulatory compliance and data integrity.
• Oversees site interactions post-activation through closeout, including patient recruitment or related activities.
• Identify data and process risks and mitigations related to the RACT.
• Review study scope, budget and protocol content; ensure team awareness of obligations.
• Use data and reports to identify risks to trial deliverables.
• Escalate risks to project manager regarding timeline, quality, or budget.
• Propose and implement risk mitigations.
• Participate in key meetings (Kick Off).
• Interact with investigators and site staff as needed.
• Collaborate with Study Start Up, Patient Recruitment and Data Management to coordinate handoffs and milestones.
• Develop and maintain study tools and templates; ensure CTMS and dashboards are usable and auditable.
• Coordinate training to study team on protocol specifics, CRF completion, dashboards and SOPs.
• Oversee resource allocations for CRAs and Central Monitors; monitor conduct and risks.
• Ensure quality and visibility of monitoring deliverables via systems/tracking.
• Review dashboards and systems to reflect timely execution of visits, duration, and frequency.
• Understand monitoring strategy; participate in risk assessment and CMP/SMP.

Skills

Team leadership

International environment

Communication skills

Problem solving

Risk management

Budget management

GCP/ICH knowledge

Computer skills

Site management

Crf/data review

Travel willingness

Monitoring strategy

Education

Bachelor’s degree or RN in a related field

Equivalent combination of education, training and experience

Tools

CTMS

EDC

Dashboard tools

Job description

Syneos Health in Warsaw, Poland seeks a Clinical Trial Manager I (Sponsor-dedicated) for a hybrid role. You will oversee site management, clinical monitoring, and central monitoring deliverables with focus on patient safety, GCP compliance, and data integrity.

You will coordinate with CRAs, central monitors, and cross‑functional teams, manage study timelines, budgets, and risk mitigation, and ensure tools and dashboards are ready for use.