Clinical Trial Manager: Flexible Site Operations Lead

Indero (formerly Innovaderm); Warszawa; On-site; PLN 180,000 - 260,000; Full time

Benefits offered by this job

Flexible schedule

Permanent FT

Comprehensive benefits

Learning & development

Job summary

Indero is seeking a Clinical Trial Manager to oversee operational management of clinical investigative sites and deliverables across trials. You will train and oversee CRAs, manage site performance, ensure adherence to study plans and budgets, and develop action plans to address issues.

The role requires strong knowledge of protocol, therapeutic area, and ICH/GCP guidelines. You will coordinate monitoring visits, risk assessment, budgeting reconciliation, and participate in sponsor and

Qualifications

• Experience performing clinical monitoring in accordance with SOPs and ICH/GCP guidelines.
• Ability to identify quality issues and implement corrective actions.
• Strong knowledge of the protocol, therapeutic area and indication.
• Excellent communication with sponsor, sites, and project team.
• Experience training and mentoring CRAs and leading meetings.

Responsibilities

• Oversee operational management of clinical investigative sites and deliverables.
• Train and oversee CRAs, Lead CRAs, and other clinical operations staff.
• Manage site screening and enrollment oversight and monitoring.
• Maintain site contact lists and coordinate site training.
• Track site visit metrics, assess protocol deviations, and drive corrective actions.
• Develop Monitoring Plans and other study materials, logs, and worksheets.
• Coordinate and lead CRA meetings and co-monitoring visits.

Skills

Clinical monitoring

SOPs & ICH/GCP

Communication with sponsors

Mentoring CRAs

Site performance analysis

Job description

Indero is seeking a Clinical Trial Manager to oversee operational management of clinical investigative sites and deliverables across trials. You will train and oversee CRAs, manage site performance, ensure adherence to study plans and budgets, and develop action plans to address issues.

The role requires strong knowledge of protocol, therapeutic area, and ICH/GCP guidelines. You will coordinate monitoring visits, risk assessment, budgeting reconciliation, and participate in sponsor and