Clinical Trial Manager

This is a fully remote position, open to applicants in Serbia.

📋 Description

• Oversee and manage the operational delivery of clinical components within a trial, which includes site selection, start-up, enrollment management, site engagement and support, monitoring planning and execution, data cleaning activities, and trial close-out.

• Ensure successful execution of assigned trials while guaranteeing the completion of all trial deliverables.

• Facilitate effective communication, regulatory documentation, and ongoing oversight of assigned trials by collaborating closely with other functional team members.

• Provide mentorship and training to team members.

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

• Lead Clinical Research Associates (CRAs) in building strong relationships with their sites to ensure high-quality oversight of monitoring, regulatory compliance, investigational product (IP) management, site payments, and overall site correspondence activities.

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

⛳️ 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 the clinical aspects of studies across multiple countries within a Contract Research Organization (CRO), Pharmaceutical, or Biotech company in a dedicated 'clinical lead' capacity.

• Extensive clinical trial management experience specifically in the oncology field.

• Familiarity with Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines, as well as the clinical development process.

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

• Proficient communication skills in the English language.

• Demonstrated proficiency in computer applications (MS Office, MS Project, PowerPoint) and software systems (CTMS, eTMF, EDC, IXRS).

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

• Core understanding of medical terminology and clinical trial activities as they relate to executing a clinical development plan.

• In-depth knowledge of ICH-GCP, relevant Precision Standard Operating Procedures (SOPs), and regulatory guidance, along with the capability to implement them effectively.

🏝️ Benefits

• Health insurance

• Flexible work arrangements

• Professional development