Company Description
Ergomed Group is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease. Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia Our company allows for employee visibility (you have a voice!) creative contribution and realistic career development. We have nourished a true international culture here at Ergomed. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. Come and join us in this exciting journey to make a positive impact in patient’s lives.
Job Description
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 withGlobal Medical Affairs Leadership on the ongoing development of the Department and contributes to thebusiness plan at both the tactical and strategic levels.
Directly and through subordinate staff, ensures thesuccessful management of medical advisory and medical monitoring projects in compliance with federalregulations, ICH Guidelines, Good Clinical Practices (GCPs) and the Company’s Standard OperatingProcedures (SOPs). Additionally, this position involves cross-functional communications, strategicplanning, and participation in clients’ strategic decision-making, physician review, medical monitoringand critical interactions with scientific advisors.The Medical Director will assist the Head of Medical Affairs in educating, mentoring and developingErgomed physicians to ensure their competence and confidence in developing their skills to becomesubject matter experts in medical monitoring. The role requires active monitoring of costs and projectdeliverables and interaction with the project managers, project directors and the Head of MedicalAffairs. Additionally, the role must include the review and implementation of efficiency strategies whilstmaintaining 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
Qualifications
QUALIFICATIONS
• 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
Additional Information
We offer:
- Training and career development opportunities internally
- Strong emphasis on personal and professional growth
- Friendly, supportive working environment
- Opportunity to work with colleagues based all over the world, with English as the company language
Our core values are key to how we operate, and if you feel they resonate with you then Ergomed is a great company to join! Quality Integrity & Trust Drive & Passion Agility & Responsiveness Belonging Collaborative Partnerships We look forward to welcoming your application.
