Clinical Trial Manager II

This is a fully remote position, open to applicants in Poland.

📋 Description

• Collaborates with the principal investigator and serves as a liaison among research subjects, client teams, investigators, and clinic operations teams while planning logistics and resource utilization.

• Monitors study progress in accordance with project milestones, client deliverables, and budget while adhering to applicable regulations both globally and regionally.

• Responsible for overseeing site management, clinical monitoring, and central monitoring deliverables, with a focus on patient safety, protocol/GCP/regulatory compliance, and data integrity.

• Manages site interactions from activation to closeout, which may involve patient recruitment, investigator payments, or other related activities.

• Reviews the study scope of work, budget, and protocol content, ensuring the clinical project team (CRAs/CeMs) is informed of contractual obligations and parameters.

• Utilizes prior clinical experience, operational data, metrics, and reports to identify risks associated with clinical trial management deliverables.

• Escalates any risks to clinical trial management deliverables (including timeline, quality, and budget) and any activities or requests that fall outside the contracted scope to the project manager.

• Engages in and presents at key meetings, such as the Kick Off Meeting.

• Acts as a point of escalation for communications with investigator site staff and may need to interact by phone or in person with principal investigators or other site staff.

• Collaborates with other functional leaders like Study Start Up, Patient Recruitment, and Data Management to ensure smooth delivery handoffs and achieve expected study milestones, such as site activation targets, enrollment targets, and database lock timelines.

• Responsible for the development and continuous maintenance of clinical study tools and templates, including the Clinical Monitoring Plan. Ensures that CTMS, dashboards, and other systems are set up and accessible for the clinical team, including overseeing user acceptance testing (UAT) as necessary.

• Ensures the quality of clinical monitoring, central monitoring, and site management deliverables within a project and maintains appropriate visibility of its progress through approved systems and/or tracking tools.

⛳️ Requirements

• Bachelor’s degree or RN in a related field, or an equivalent combination of education, training, and experience.

• Proven ability to lead and align teams towards achieving project milestones.

• Demonstrated capability to work effectively in an international environment.

• Proven 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 is essential.

• Knowledge of Good Clinical Practice/ICH Guidelines and other relevant regulatory requirements.

• Proficient computer skills are a must.

• Strong conflict resolution skills are essential.

• Proven ability to apply problem-solving techniques to address complex issues and utilize a risk management approach to identify and mitigate potential threats to the successful execution of a clinical research project.

• Demonstrates critical thinking to ascertain the root cause and appropriate solution when identifying issues.

🏝️ Benefits

• We are dedicated to developing our people through career advancement and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition; and a comprehensive rewards program.

• We are committed to fostering an inclusive culture where you can authentically be yourself.