Clinical Trial Manager

Posted 5 days agoViewed
UKHungaryPolandRomaniaSerbiaSlovakiaFull-TimeCRO, Pharma, Biotech
Company:Precision Medicine Group
Location:UK, Hungary, Poland, Romania, Serbia, Slovakia
Languages:English
Seniority level:Manager, Significant clinical trial management experience
Experience:Significant clinical trial management experience
Skills:
LeadershipProject ManagementCross-functional Team LeadershipOperations ManagementMicrosoft OfficeMentoringComplianceQuality AssuranceTeam managementStakeholder managementComputer skillsClient relationship managementRisk Management
Requirements:
Bachelor’s degree or equivalent combination of education/experience in science or health-related field Experience in the field of oncology Demonstrable experience leading clinical aspects of studies across multiple countries in a CRO / Pharma or Biotech company 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) Software experience (CTMS, eTMF, EDC, IXRS) Demonstrated ability to develop positive working relationships Demonstrates core understanding of medical terminology and clinical trial activities Demonstrates mastery knowledge of ICH-GCP, meaningful Precision SOPs, and regulatory guidance
Responsibilities:
Management and operational delivery of clinical elements within a trial 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) Mentoring and training of team members Identify challenges to study timelines/deliverables and offer creative action plans Lead CRAs in establishing relationships with their sites for high quality oversight Maintain team focus on study priorities through efficient cross-functional partnerships
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