Clinical Trial Manager

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

📋 Description

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

• Successfully carry out assigned trials and ensure the fulfillment of trial deliverables.

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

• Provide mentorship and training to fellow team members.

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

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

• Maintain a focus on study priorities by fostering cross-functional partnerships and communication to ensure client satisfaction.

⛳️ Requirements

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

• Proven experience 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 specifically in oncology.

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

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

• Must possess effective communication skills in the English language.

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

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

• Understanding of medical terminology and clinical trial processes related to the execution of clinical development plans.

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

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

🏝️ Benefits

• Remote work arrangement.

• Regular full-time employment.

• Ongoing support for professional development.

• Opportunities for mentoring and training.

• Opportunities for domestic and international travel.