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

Ergomed•Raleigh, NC

About The Position

The 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. 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.

Requirements

Proven, efficient medical communication
Highly organized, with strong interpersonal, presentational, and documentation skills
Proven efficiency in timely delivery
Self-motivated, able to work independently, as well as in multi-disciplinary teams, and with the intellectual flexibility to continually develop and learn new skills
In-depth knowledge of medical terminology and of GCP, ICH guidelines relevant to global drug safety and drug development process and regulations
Good decision-making and problem resolution based on all relevant information.
Strategic thinking, recognizing key issues and providing practical solutions
Ability to work effectively in an environment characterized by tight timelines and changing priorities.
Excellent Leadership skills

Responsibilities

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.
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).
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