Global Clinical Trial Leader – FSP

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

📋 Description

• Oversee the planning, execution, and monitoring of clinical trial processes.

• Supervise trial preparations, ensuring alignment and progress among trial team members.

• Assist in the creation of trial-level documents managed by other departments.

• Validate and contribute to country allocation while overseeing trial feasibility.

• Develop and implement engagement plans, recruitment strategies, and risk mitigation for trials.

• Lead the creation of essential trial and patient-facing documentation.

• Maintain oversight throughout the clinical trial process, ensuring compliance with GCP, regulations, SOPs, and risk monitoring.

• Assist with budget management, clinical quality monitoring, SMC/DMC oversight, and safety reporting.

• Prepare and implement amendments to core documents, including training updates and retraining sessions.

• Support responses to requests from authorities and ethics committees.

• Manage outsourced vendor services, including Central Lab services.

• Ensure the timely cleaning and delivery of clinical trial data.

• Coordinate and assist the trial medical writer in the preparation of the Clinical Trial Report (CTR).

• Ensure the timely, complete, and compliant archiving of global documents in the Trial Master File (TMF).

• Aid in the disclosure of results and documentation for global registries.

• May assist in the publication of trial data.

⛳️ Requirements

• A degree is required; a master’s degree is preferred.

• At least 5 years of experience in clinical trial management.

• Significant experience in managing clinical trial projects across international settings.

• Global experience in clinical research, healthcare, or a regulated environment.

• Strong background in clinical trial project management.

• Comprehensive understanding of project management and teamwork dynamics.

• Familiarity with ICH-GCP, regulatory standards, and clinical trial processes.

• Excellent communication, organizational, and problem-solving abilities.

• Proficiency in English, both written and spoken.

• Experience in Oncology, CNS, Immunology, or Vaccines is preferred.

🏝️ Benefits

• Opportunity to work remotely or from home in Germany.

• Flexible working arrangements.

• Opportunities for professional growth.

• Continuous learning opportunities available.

• Possibility to explore various career paths and enhance skills within clinical research.