Clinical Study Manager – StaffPoint Oy, Turku
5.12.2020Työtehtävän kuvaus
If you are an experienced Clinical Study Manager with a passion for planning and executing Clinical Studies together with a team of colleges in an international environment – this could be your next career move.
You are probably known for your scientific curiosity and ability to understand different therapeutic areas as well as collaborating with a cross functional team. Radiometer has a diverse and technologically advanced line of Medical Devices that is used for diagnosing a broad group of patients worldwide.
It is your opportunity to lead and execute clinical studies, collaborate with doctors and nurses to identify which sites are most suitable to conduct studies with. Furthermore, you can look forward to being a key contributor internally when you communicate the progress of clinical studies to key stakeholders.
Responsibilities
You can expect to:
• Manage global clinical trials and programs associated with all RMED’s business areas to support global registrations
• Represent the Sponsor in clinical study planning, study design, study execution and study closeout. Examples of deliverables include clinical protocol, monitoring plan, site budgeting, contracting and Trial Master File.
• Lead the Study team and on a daily basis proactively lead study execution within budget along with your Clinical peers.
• Collaborate with other functions (data management, regulatory, quality, R&D, Marketing and Operations, legal) as well as external partners (investigators, subject matter experts, Contract Research Organizations) on clinical study deliverables
• Proactively identify clinical project risks, provide input to appropriate counter-measures and contingency plans and assure implementation of action plans to reduce project risk and meet clinical study timelines
The assignments require you to maintain knowledge about clinical input required by European regulators, ISO, FDA and Good Clinical Practice (GCP). You also get to collaborate cross-functionally with data managers, regulatory, quality, R&D, Marketing and Operations. Collaboration with external partners such as investigators, subject matter experts and Contract Research Organizations on product development process deliverables are also part of the job.
The job requires travelling up to 40% of your time.
Edellytämme sinulta
- Bachelor of Science (B.Sc.) or Master of Science (M.S.) in a scientific, biological or medical science discipline is required. This combined with the following increases your chances of success in the job:
- More than 5 years of experience in leading clinical study execution as a Clinical Study Manager
- Knowledge of how to apply clinical development expertise to create excellent clinical protocols and being able to inspire trust and respect among international colleagues
- Experience with successful proactive planning and leading clinical study execution for clinical diagnostics and/or medical devices in a regulated environment
- Demonstrated solid track record of successful results and in leading collaboration in effective teams and getting work done through others
- Demonstrated strong ability to understand complex scientific, engineering and business concepts
- Clinical experience with Blood Gas testing, Transcutaneous Monitoring and Immunoassays testing is an advantage.
- On a personal level you are positive, energetic, structured and organized combined with a having a high level of ethical standards.
Tarjoamme sinulle
- A unique opportunity to work in the field of medical technologies, where knowledge sharing and professional respect combine to make it both fun and meaningful to go to work. Both in Finland and abroad you will meet enthusiastic colleagues who take pride in making a difference in a company whose products can truly impact other people’s lives. Developing on a personal and professional level is of a high importance for everyone in Radiometer and that is why we have many employees building and developing their careers for many years in Radiometer and Danaher.
Hakuohjeet ja lisätiedot
Application deadline is December 15, 2020. Please attach your CV and other relevant documents. We look forward to receiving your application.
If you fulfil the requirements for the job and need more information, please contact StaffPoint / Mikko Lepistö, +358405100433 or mikko.lepisto@staffpoint.fi