Clinical Trial Manager

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

📋 Description

• Oversee and operationally execute clinical components within 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.

• Maintain effective communication, regulatory documentation, and ongoing supervision of assigned trials through close collaboration with functional team members.

• Provide mentorship and training to team members.

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

• Guide CRAs in forming site relationships and managing monitoring, regulatory, investigational product, site payment, and site correspondence activities.

• Keep the team focused on study priorities through cross-functional collaborations and effective communication to ensure client satisfaction.

• Act as the central intelligence hub for the studies being managed.

• Direct CRAs and supervise the clinical elements of studies across various countries, ensuring adherence to timelines, scope, and quality standards.

⛳️ Requirements

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

• Proven experience in leading the clinical aspects of studies across multiple countries in a CRO, Pharma, or Biotech setting in a dedicated clinical lead role.

• Extensive clinical trial management experience in oncology.

• Experience with CAR-T and Radiopharmaceuticals is highly desirable.

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

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

• Proficient communication skills in the English language.

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

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

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

• Fundamental understanding of medical terminology and clinical trial activities related to the execution of a clinical development plan.

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

• Candidates must have legal authorization to work in the country of employment without requiring employer sponsorship.

🏝️ Benefits

• Remote work opportunities.

• Potential for ongoing professional growth and development.

• Opportunities for mentoring and training of team members.

• Domestic and international travel opportunities.

• Commitment to equal opportunity employment.

• Reasonable accommodations available for applicants with disabilities.