Clinical Trial Manager

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

📋 Description

• Oversee and operationally implement the clinical aspects of trials, which include site selection, initiation, management of enrollment, site engagement and support, planning and execution of monitoring, data cleaning, and trial closure.

• Successfully execute assigned trials, ensuring that all trial deliverables are met.

• Facilitate effective communication, maintain regulatory documentation, and provide ongoing oversight of assigned trials in collaboration with cross-functional team members.

• Provide mentorship and training to team members.

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

• Guide CRAs in establishing relationships with sites and supervising monitoring, regulatory, investigational product, site payment, and site correspondence activities.

• Maintain a focus on study priorities through cross-functional collaboration and communication to ensure client satisfaction.

⛳️ Requirements

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

• Proven experience in leading clinical components of studies across multiple countries within a CRO, Pharma, or Biotech company in a dedicated clinical lead position.

• Extensive clinical trial management experience specifically in oncology.

• Strong working knowledge of GCP/ICH guidelines and the clinical development process.

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

• Must possess effective communication skills in English.

• Proficient in computer applications such as MS Office, MS Project, and PowerPoint.

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

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

• Solid understanding of medical terminology and clinical trial activities related to the execution of clinical development plans.

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

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and growth.