Clinical Trial Manager

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

📋 Description

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

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

• Facilitate communication, manage regulatory documentation, and maintain ongoing oversight of assigned trials in partnership with functional team members.

• Provide mentorship and training to team members.

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

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

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

⛳️ Requirements

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

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

• Extensive clinical trial management experience specifically in oncology.

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

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

• Proficient in effective communication in English.

• Demonstrated proficiency in computer applications including MS Office, MS Project, and PowerPoint.

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

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

• Fundamental knowledge of medical terminology and clinical trial activities related to the execution of clinical development plans.

• Mastery of ICH-GCP, relevant Precision Standard Operating Procedures (SOPs), and regulatory guidelines.

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

🏝️ Benefits

• Opportunity for remote work.

• Support for professional growth and ongoing development.

• Access to mentoring and training opportunities.