Start-Up and CTMA Line Manager Full Time

Responsibilities:

• Line manage Study Start-Up (SSU) and Clinical Trial Manager Associates.
• Deliver country SSU and CTMA on time, maintaining high quality.
• Monitor SSU and CTMA activities against KPIs.
• Drive best practices and process improvements.
• Provide country-specific SSU and CTMA expertise to project teams.
• Act as SSU and CTMA Lead backup as needed.
• Ensure timely follow-ups, issue resolutions, and report updates.
• Manage and maintain SSU and CTMA resources.
• Conduct site feasibility and strategic recommendations.
• Drive kick-off and task completion from site selection to activation.
• Oversee Ethics Committee and Regulatory Authority submissions.
• Review and agree on project planning and timelines.
• Prepare and submit documents to central IRB.
• Support clinical teams with operations tasks and TMF quality.
• Ensure regulatory submissions are completed post-approvals.
• Lead SSU and CTMA Forum discussions and support data entry in CTMS.
• Streamline local workflows for efficient output.
• Manage vendor qualification and serve as a contact for issues.
• Oversee translation for ethical and regulatory documents.
• Interview and onboard new hires, ensure training compliance.
• Conduct 1:1s for feedback, workload assessment, and goal tracking.
• Perform mid-year and year-end performance reviews.
• Engage in FSP leadership team meetings.

Requirements:

• Bachelor’s degree or higher in a scientific or healthcare field.
• Minimum 5 years in clinical research or clinical operations.
• Proficient in Microsoft Office Suite.
• Knowledge of ICH/GCP clinical trial execution.
• Strong task prioritization skills.
• Excellent written and verbal communication.
• Highly organized and diligent in follow-up.
• Risk mitigation skills.
• Line management experience.
• Experience in Functional Service Provider models.
• Mentoring and training capabilities.
• Fluent in Polish and English (verbal and written).
• Up to 10% travel requirement.

Benefits:

• Equal opportunity employer.
• Emphasis on patient-first values and collaborative spirit.
• Encourages continuous learning and innovation.
• Committed to workplace diversity and inclusivity.