Clinical Trial Manager

Summary

Join Precision for Medicine as a Clinical Trial Manager and lead the clinical aspects of studies across multiple countries. You will be responsible for managing CRAs, ensuring timeline adherence, and delivering high-quality results. The ideal candidate is client-focused, well-organized, and excels at risk management. Remote work is available in several European countries. This role involves managing all clinical trial elements, mentoring team members, and collaborating with cross-functional teams to achieve client satisfaction. Precision for Medicine offers a unique opportunity to contribute to the advancement of precision medicine in oncology.

Requirements

• Bachelor’s degree or equivalent combination of education/experience in science or health-related field, including experience in the field of oncology
• Demonstrable experience leading clinical aspects of your studies across multiple countries in a CRO / Pharma or Biotech company (in a dedicated 'clinical lead' role)
• Significant clinical trial management experience in the area of oncology
• Working knowledge of GCP/ICH guidelines and the clinical development process
• Availability for domestic and international travel including overnight stays
• Must be able to communicate effectively in the English language
• Demonstrated computer skills (MS Office, MS Project, PowerPoint) and software experience (CTMS, eTMF, EDC, IXRS)
• Demonstrated ability to develop positive working relationships with internal and external organizations
• Demonstrates core understanding of medical terminology and clinical trial activities as it relates to the execution of a clinical development plan
• Demonstrates mastery knowledge of ICH-GCP, meaningful Precision SOPs, and regulatory guidance, as well as the ability to implement

Responsibilities

• Management and operational delivery of the clinical elements within a trial including site selection, start-up, enrolment management, site engagement and support, monitoring planning and execution, data cleaning activities and close-out
• Successful execution of assigned trials and ensuring completion of trial deliverables
• Ensure appropriate communication, regulatory documentation, and ongoing oversight of assigned trial(s) by working in close collaboration with other functional team members
• Mentoring and training of team members
• Identify challenges to study timelines/deliverables and offer creative action plans to the team/sponsor
• Lead CRAs as they establish relationships with their sites for high quality oversight of monitoring, regulatory, IP, site payment and overall site correspondence activities
• Maintain team focus on study priorities through efficient cross-functional partnerships and effective communication to achieve the highest level of client satisfaction

Benefits

Remote work is available in UK, Spain, Hungary, Poland, Romania, Serbia or Slovakia