Global Clinical Trial Leader – FSP

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

📋 Description

• Oversee the planning, execution, and monitoring of clinical trial processes, including risk management strategies.

• Develop and manage trial timelines and preparation activities.

• Assist in the creation of trial-level documents managed by Statistics, Data Management, Study Physician, Medical Writing, and Site Monitoring teams.

• Evaluate and contribute to country allocation while overseeing trial feasibility assessments.

• Create and execute trial engagement strategies, recruitment plans, and risk management initiatives.

• Lead the creation of essential trial documents and those intended for patients.

• Ensure compliance with GCP, regulatory standards, SOPs, and risk management throughout the trial execution.

• Assist in budget management, clinical quality assurance, SMC/DMC oversight, and safety reporting activities.

• Prepare and implement modifications to core documents, including updates and retraining materials.

• Aid in addressing inquiries from authorities and ethics committees.

• Oversee the services provided by outsourced vendors, including Central Lab services.

• Guarantee the prompt cleaning and submission of clinical trial data.

• Facilitate and support the trial medical writer in delivering the Clinical Trial Report (CTR).

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

• Assist in the disclosure of results and documents in global registries.

• May contribute to the publication of trial outcomes.

⛳️ 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 expertise in clinical research, healthcare, or within a regulated environment.

• Proven strong project management skills in clinical trials.

• Comprehensive understanding of project management and teamwork to foster high-performance teams.

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

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

• Proficiency in English, both written and spoken.

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

🏝️ Benefits

• Flexible work arrangements.

• Opportunities for growth and continuous learning.

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