Clinical Trial Manager

This is a fully remote position, open to applicants in Spain, +6 more countries.

📋 Description

• Oversee and operationally implement the clinical components of trials, which include site selection, initiation, enrollment management, site engagement and support, planning and executing monitoring, data cleaning, and trial close-out.

• Successfully execute assigned trials and ensure that all trial deliverables are met.

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

• Guide and train team members.

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

• Direct CRAs in building site relationships and supervising monitoring, regulatory, investigational product, site payment, and site correspondence activities.

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

• Act as the central intelligence hub for managed studies, overseeing clinical aspects across various countries.

⛳️ Requirements

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

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

• Extensive clinical trial management experience specifically in oncology.

• Familiarity with CAR-T and Radiopharmaceuticals is considered a strong advantage.

• 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.

• Demonstrated computer proficiency with MS Office, MS Project, and PowerPoint.

• Experience 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 a clinical development plan.

• Mastery of ICH-GCP, Precision SOPs, and relevant regulatory guidance.

• Must possess legal authorization to work in the country of employment without employer sponsorship.

🏝️ Benefits

• Flexible remote work arrangement.

• Opportunities for ongoing professional development.

• Mentorship and training opportunities for team members.

• Travel opportunities, both domestic and international.