Senior International Trial Manager working with Digital Health - Denmark
Want to know company name or location? Company managed [?]
- The Digital Health revolution is at its beginning and our company is branching out into this new area.
- If you want to be part of something new then we have an exciting opportunity for the experienced Senior International Trial Manager with a passion for new technologies and a focus on how digital health can strengthen clinical development.
- In Global Development, we are responsible for managing clinical drug development worldwide from early development phases to product introduction.
- We ensure medical and scientific documentation for clinical submissions and authorities while ensuring that the process lives up to uniform global standards, regulations and business ethics.
- We work in global project teams with focus on delivering viable products that make a difference to patients and ultimately benefit society.
About the department
- Trial Operations, Insulin & Devices, is responsible for the set-up and execution of phase 2-4 studies within our diabetes, device and digital health portfolio.
- We are a large area of approximately 70 enthusiastic colleagues such as International Trial Managers, Clinical Trial Administrators and Clinical Project Managers divided into 5 departments.
- Our environment is characterised by a vast global network, knowledge sharing and challenging assignments in a dynamic project centric organisation which offers continuous personal and professional development opportunities.
- As Senior International Trial Manager you will be responsible for timely planning, execution and finalization of clinical trials within Digital Health, using your operational and therapeutic experience. You will chair the International Study Group and ensure coordination and progress of trial management activities in a proactive way through clear communication and great teamwork.
- Organizing and executing project meetings as well as planning, preparing and presenting at global Investigator and Monitor meetings are also part of your tasks.
- As Digital Health is a new area within our company, we expect you to be excited about establishing new processes and working within a field with no predefined path.
- You have an end-to-end perspective and are able to evaluate the consequence for different stakeholders when developing new processes.
- You hold a university degree in biological, pharmaceutical or health science or equivalent with at least 5 years of experience in trial management related positions and with significant project management responsibilities.
- A broad knowledge of clinical trial methodology as well as great communication, presentation and negotiation skills are required.
- You have a proven track record of ensuring progress of trial activities to meet deadlines within budget.
- A quality mind-set is a must combined with the ability to know how to prioritize between different tasks.
- You are a dedicated team player with a high degree of flexibility and cross-cultural awareness.
- You have a structured and analytical approach when developing trial documents such as protocols, monitoring guidelines, recruitment and retention strategies, risk management plans, communication plans etc.
- You sense the importance of detail when setting up a trial and providing input to clinical IT systems.
- You have IT flair, a strong data process understanding and are able to digest and understand complex data.
- Experience with outsourcing of monitoring to CROs is an advantage.
- Proficiency in written and spoken English is essential.
Working with Us:
- Your skills, dedication and ambition help us change lives for the better.
- In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.