Clinical Trial Manager

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

📋 Description

• Oversee and operationally implement clinical components within trials, which include site selection, initiation, enrollment management, site engagement and support, planning and executing monitoring, data cleaning, and trial closure.

• Successfully execute designated trials and ensure the fulfillment of trial deliverables.

• Ensure effective communication, regulatory documentation, and continuous oversight of designated trials.

• Collaborate effectively with members of cross-functional teams.

• Mentor and train team members.

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

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

• Maintain concentration on study priorities through effective communication and partnerships across functions.

• Act as the central intelligence hub for managed studies, overseeing clinical elements across various countries.

⛳️ Requirements

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

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

• Extensive clinical trial management experience in oncology.

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

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

• Must possess strong communication skills in English.

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

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

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

• Fundamental understanding of medical terminology and clinical trial processes 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 requiring employer sponsorship.

🏝️ Benefits

• Option for remote work.

• Mentorship and training opportunities for team members.

• Equal Opportunity Employer.

• Reasonable accommodations available during the application process.