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, prioritizing patient safety, protocol/GCP/regulatory compliance, and data integrity.

• Manage site interactions from activation to closeout, including recruitment and payments to investigators.

• Identify critical risks related to data, processes, and protocol execution, and devise mitigation strategies.

• Review the scope of work, budgets, and protocols; ensure clinical project teams are aware of contractual obligations.

• Recognize and escalate risks that may impact timelines, quality, budget, and contracted scope.

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

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

• Collaborate with Study Start-Up, Patient Recruitment, Data Management, and other departments to achieve study milestones.

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

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

• Organize training on protocols, CRF completion, dashboards, SOPs, clinical plans, data plans, and timelines.

• Oversee CRA and Central Monitor resourcing, site assignments, and management of conduct and delivery risks.

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

• Review CTMS, EDC, eDiary, ePRO, TMF, IVRS/IWRS, and monitoring dashboards for timely operational execution.

• Ensure that assigned clinical team members comprehend and adhere to monitoring strategies, plans, and risk controls.

• Review monitoring documentation to ensure revisions, approvals, and delivery deadlines are achieved.

• Provide status updates and solutions to clients, project management, and leadership.

• Assist in inspection readiness, corrective action plans, data cuts, and database lock deadlines.

• Offer performance feedback to line managers.

• May be tasked with larger, more complex trials.

⛳️ Requirements

• A Bachelor’s degree or RN in a relevant 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.

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

• Preferred experience in risk-based monitoring.

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

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

• Proficient computer skills.

• Excellent communication, presentation, and interpersonal abilities.

• Strong conflict resolution skills.

• Fluency in both German and English.

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

• Critical thinking skills to identify issues and formulate suitable solutions.

• Approximately 20% travel may be necessary.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical and therapeutic area training.

• Peer recognition.

• Total rewards program.

• An inclusive culture.