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
Provides leadership to the global medical function including medical monitoring. Contributes to 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 Senior 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.Interact with executive leadership, customers, business development, and project teams to drive the medical strategy globally.
CORE 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 projects
- Interacts with other departments to ensure the required quality of service is provided to a sponsor
- Providing project status reports and metrics to the VP of Global Medical Affairs during regular group meetings, in order to optimize performance (with particular reference to the amount of data, timelines, identifying issues and resolution involved)
- Keeping up to date with current and scientific knowledge in their area of expertise in order to provide high efficiency
- Business development support, proposal budget approval, out of scope approval
- Overseeing and managing a group of medical monitors/SP/medical directors
- Responsible for personnel training to meet job description requirements; responsible for personnel career development in the function
Qualifications
- Medical Doctor degree.
- Additional board certification and/or medical specialty preferred
- Active medical licenses are preferable but not mandatory.
- Extensive experience in clinical research in medical monitoring
- Strong team management background at the global level
- Expertise and extensive clinical research experience
- Experience in corporate leadership involvement and strategic contribution
- Business development experience, including review of proposals, budgets, and bid defense meeting participation required
- 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
- Strong coaching and mentoring skills; ability to develop and manage staff performance
- Eagerness to engage in new business contacts and grow Ergomed’s business/client base
Additional Information
Why Ergomed We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow. To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us. 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.
