Clinical Trial Manager

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

📋 Description

• Oversee and operationally implement clinical components within trials, including site selection, initiation, enrollment management, site engagement and support, monitoring planning and execution, data cleaning, and close-out.

• Successfully execute assigned trials and ensure the achievement of trial deliverables.

• Ensure effective communication, regulatory documentation, and continuous oversight of assigned trials in collaboration with team members from various functions.

• Provide mentorship and training to team members.

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

• Lead Clinical Research Associates (CRAs) in building site relationships and managing monitoring, regulatory, investigational product, site payment, and site correspondence activities.

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

• Act as the central hub of intelligence for managed studies and lead CRAs across various countries.

⛳️ Requirements

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

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

• Extensive clinical trial management experience in oncology.

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

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

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

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

• Mastery of ICH-GCP, relevant Precision SOPs, and regulatory guidance, with the capability to implement them.

• Candidates must be legally authorized to work in the country of employment without requiring employer sponsorship.

🏝️ Benefits

• Option for remote work.

• Regular full-time employment.

• Support for professional growth and ongoing development.

• Opportunities for mentoring and training.

• Chance to work on clinical trials related to oncology and rare diseases.

• Equal Opportunity Employer.

• Reasonable accommodations available for applicants with disabilities.