Clinical Trial Manager – Single Sponsor

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

📋 Description

• Oversee site management, clinical monitoring, and central monitoring deliverables with an emphasis on patient safety, adherence to protocols/GCP/regulatory standards, and data integrity.

• Supervise site interactions from the initiation stage to closure, including recruitment efforts, investigator compensation, and related tasks.

• Identify potential clinical trial risks and establish strategies for risk mitigation.

• Collaborate with the clinical project team to review study scope, budget, protocol details, and contractual commitments.

• Raise concerns regarding timelines, quality, budget, and risks that fall outside the project scope to the project manager.

• Engage in and present at essential meetings, such as Kick-Off Meetings.

• Act as a point of escalation for communications with investigator sites and maintain interactions with principal investigators and site personnel.

• Coordinate delivery transitions with the Study Start-Up, Patient Recruitment, and Data Management teams.

• Create and sustain clinical study tools and templates, including Clinical Monitoring Plans.

• Ensure that CTMS, dashboards, and other systems are properly configured and accessible, including supervising UAT and audit trail evaluations.

• Organize study-team training on protocols, CRFs, dashboards, SOPs, plans, data, and timelines.

• Manage CRA and Central Monitor resources, site assignments, conduct, and delivery risks.

• Track the quality and advancement of clinical monitoring, central monitoring, and site management deliverables.

• Review clinical trial systems and dashboards, including CTMS, EDC, eDiary, ePRO, TMF, IVRS/IWRS, and central monitoring dashboards.

• Ensure compliance with monitoring strategies, CMP/SMP, and risk management plans.

• Assess site and central monitoring documentation, ensuring prompt revisions, approvals, and delivery.

• Provide updates to clients, project management, and leadership regarding deliverables and associated risks.

• Assist in preparation for inspections, development of corrective action plans, data cuts, and database lock timelines.

• Supervise CRAs and Central Monitors while providing performance feedback to their line managers.

⛳️ Requirements

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

• Proven ability to lead and unify teams to meet project milestones.

• Demonstrated ability to work effectively in an international setting.

• Established expertise in site management and monitoring (clinical or central).

• Preferred experience in risk-based monitoring.

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

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

• Proficient computer skills.

• Excellent communication, presentation, and interpersonal abilities.

• Strong skills in conflict resolution.

• Fluency in both German and English.

• Capability to employ problem-solving techniques for complex issues and utilize a risk-management approach.

• Critical thinking skills to identify challenges and determine effective solutions.

• Willingness to travel approximately 20%.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical skills and therapeutic areas.

• Peer recognition initiatives.

• Comprehensive total rewards program.

• A culture that promotes authenticity and a sense of belonging.

• Initiatives focused on diversity, inclusion, and fostering a sense of belonging.