Medical Director / Senior Medical Monitor (extensive oncology experience required)

The Medical Director  Senior Medical Monitor within the ERGOMED Global Medical Affairs is responsible for providing medical monitoring and medical safety expertise to enable high quality and efficiency in the ERGOMED Global Medical Affairs and providing Medical Monitoring tasks including those of higher complexity.

Provides leadership to the global medical function including medical monitoring. Collaborates with

Global Medical Affairs Leadership on the ongoing development of the Department and contributes to the

business plan at both the tactical and strategic levels. Directly and through subordinate staff, ensures the

successful management of medical advisory and medical monitoring projects in compliance with federal

regulations, ICH Guidelines, Good Clinical Practices (GCPs) and the Company’s Standard Operating

Procedures (SOPs). Additionally, this position involves cross-functional communications, strategic

planning, and participation in clients’ strategic decision-making, physician review, medical monitoring

and critical interactions with scientific advisors.

The Medical Director will assist the Head of Medical Affairs in educating, mentoring and developing

Ergomed physicians to ensure their competence and confidence in developing their skills to become

subject matter experts in medical monitoring. The role requires active monitoring of costs and project

deliverables and interaction with the project managers, project directors and the Head of Medical

Affairs. Additionally, the role must include the review and implementation of efficiency strategies whilst

maintaining the highest quality of work.

ROLE AND RESPONSIBILITIES

• Provides all levels of medical monitoring activities including patient safety surveillance and integrity.
• Included in multi-cross-functional support to the project team in conducting clinical trials
• Could act as the main point of contact with the sponsor as a medical representative
• Coordination and delivery of trainings, supervision, and oversight of Medical Monitors
• Main point of contact and escalation for Medical Monitors
• Participation in the development and revision of Medical Monitoring SOPs
• Assists with the assignment, transitioning, and assimilation of individuals to work as Medical Advisors, Medical Monitors and Study Physicians on project.
• Interacts with other departments to ensure the required quality of service is provided to a sponsor