CRP/上市前医学经理

该职位来源于猎聘

• Perform medical monitoring work as per project scope and Medical Monitoring Plan with a larger portion as a global/program level medical monitor.
• Keep up to date with current and scientific knowledge in the medical field.
• Work closely with business development and other internal stakeholders in critical appraisal of protocols, proposing study designs and endpoint development.
• Regular participation in project proposals/bid defence meetings and client liaison.
• Set up/support drug safety monitoring boards (DSMB), adjudication committees.
• Participate in global/program level governance committee reviews.
• Lead with a data-driven and compliance mindset including detection of trends and outliers, signal detection.
• Provide technical medical support to the team through own medical knowledge.
• Coordinate, supervise, coach and support assigned medical monitors in order to improve their service delivery.
• Act as Medical Advisor in area of specialism, supporting MMs on a study
• Mentor/line manage assigned medical monitors.
• Participate in the development and revision of medical monitoring SOPs.
• Participate in quality control review and assessment of medical monitoring team performance.
• Update teams’ performance progress and any issues arising promptly to management.
• Manage the fast flow of day-to-day operations.
• Actively participate in recruitment and interviews for new hires.
• Maintain confidentiality to operate in the role with the highest of ethical and quality standards.