Clinical Trial Manager

This is a fully remote position, open to applicants in Hungary, +4 more countries.

📋 Description

• Oversee and operationally execute clinical components of trials, encompassing site selection, initiation, enrollment management, site engagement and support, monitoring planning and execution, data cleaning, and trial close-out.

• Successfully implement assigned trials and ensure the fulfillment of trial deliverables.

• Facilitate effective communication, maintain regulatory documentation, and provide continuous oversight of assigned trials in partnership with functional team members.

• Guide and mentor team members.

• Recognize potential challenges to study timelines and deliverables, and propose innovative action plans to the team and sponsor.

• Direct CRAs in managing site relationships and overseeing monitoring, regulatory compliance, investigational product, site payments, and site correspondence activities.

• Maintain a strong focus on study priorities through collaboration and effective communication to ensure client satisfaction.

⛳️ Requirements

• Bachelor’s degree or equivalent combination of education and experience in a science or health-related field, including experience in oncology.

• Proven experience leading clinical aspects of studies across multiple countries in a CRO, pharmaceutical, or biotech company in a dedicated clinical lead role.

• Extensive clinical trial management experience in oncology.

• Solid understanding of GCP/ICH guidelines and the clinical development process.

• Willingness to travel domestically and internationally, including overnight stays.

• Proficient communication skills in English.

• Strong computer skills in MS Office, MS Project, and PowerPoint.

• Familiarity with CTMS, eTMF, EDC, and IXRS software.

• Proven ability to foster positive working relationships with both internal and external organizations.

• Fundamental understanding of medical terminology and clinical trial activities related to executing clinical development plans.

• In-depth knowledge of ICH-GCP, Precision SOPs, and regulatory guidance, with the capability to implement them effectively.

• Legally authorized to work in the country of employment without the need for employer sponsorship.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Opportunities for professional development and continuing education.

• Flexible work arrangements.

• Supportive team environment and culture.