Clinical Trial Manager

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

📋 Description

• Provide oversight for site management, clinical monitoring, and central monitoring deliverables, prioritizing patient safety, adherence to protocols/GCP/regulatory standards, and data integrity.

• Manage site interactions from post-activation to closeout, focusing on patient recruitment and investigator payments.

• Identify critical risks associated with data, processes, and protocol execution, and propose mitigation strategies.

• Review the study's scope of work, budget, and protocol content; ensure the clinical project team is aware of contractual obligations and parameters.

• Identify and escalate risks related to timelines, quality, and budget, including activities that are out of scope.

• Participate in and present at key meetings, such as Kick-Off Meetings.

• Act as a point of escalation for communications with investigator site staff and engage with principal investigators and site personnel.

• Coordinate the handoff of deliverables with Study Start-Up, Patient Recruitment, and Data Management to achieve study milestones.

• Develop and maintain clinical study tools and templates, including the Clinical Monitoring Plan.

• Ensure that CTMS, dashboards, and other systems are properly configured and accessible, overseeing UAT and access/audit trail reviews.

• Organize training for the study team on protocol requirements, CRF completion, dashboards, SOPs, plans, and timelines.

• Oversee the resourcing of CRAs and Central Monitors, site assignments, and study team conduct.

• Guarantee the quality and visibility of clinical monitoring, central monitoring, and site management deliverables.

• Review oversight dashboards and clinical trial systems such as CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS, and central monitoring dashboards.

• Ensure that assigned clinical team members are aware of and comply with monitoring strategies, CMP/SMP, and risk management plans.

• Review documentation from site and central monitoring, ensuring revisions, approvals, and deadlines are met.

• Communicate with clients, functional departments, project management, and leadership to provide status updates and propose solutions.

• Assist in preparation for inspection readiness related to clinical trial management.

• Supervise CRAs and Central Monitors, assess compliance, and identify emerging risks.

• Develop and implement corrective action plans and activities to meet data cut and lock deadlines.

• Provide performance feedback to line managers.

⛳️ 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 to achieve project milestones.

• Demonstrated experience working in an international environment.

• Proven expertise in site management and monitoring (both clinical and central).

• Preferred experience in risk-based monitoring.

• Understanding of clinical trial management financial principles and budget oversight.

• Familiarity with Good Clinical Practice/ICH Guidelines and other relevant regulatory requirements.

• Proficient computer skills.

• Strong communication, presentation, and interpersonal abilities.

• Excellent conflict resolution skills.

• Fluency in both German and English.

• Ability to apply problem-solving techniques to address complex issues and utilize a risk management approach.

• Critical thinking skills to identify causes and appropriate solutions when issues arise.

• Moderate travel may be required, approximately 20%.

🏝️ Benefits

• Career development and progression opportunities.

• Supportive and engaged line management.

• Technical and therapeutic area training provided.

• Peer recognition initiatives.

• Comprehensive total rewards program.

• Inclusive organizational culture.

• Reasonable accommodations provided when appropriate.