Clinical Trial Manager

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

📋 Description

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

• Successfully carry out assigned trials and ensure all trial deliverables are met.

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

• Provide mentorship and training to team members.

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

• Guide Clinical Research Associates (CRAs) in developing site relationships and supervising monitoring, regulatory, investigational product, site payment, and correspondence activities.

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

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

⛳️ Requirements

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

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

• Substantial clinical trial management experience specifically in oncology.

• Comprehensive 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 proficiency with MS Office, MS Project, and PowerPoint.

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

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

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

• Expertise in ICH-GCP, applicable Precision SOPs, and regulatory guidance, with the capacity to implement these standards.

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

🏝️ Benefits

• Competitive salary and comprehensive benefits package.

• Opportunities for professional development and career advancement.

• Supportive work environment that values collaboration and innovation.