Danaher Corporation Clinical Study Manager in Brønshøj, Denmark
Danaher Company Description
At Radiometer, our mission is to help caregivers make diagnostic decisions that save lives. To provide caregivers the insight and confidence that help them arrive at the right diagnostic decisions – decisions that in the end help save lives.
On a yearly basis millions of lives are touched by the information our solutions provide and that’s a fact, we take very seriously; the more critical the setting, the greater the requirements are and that’s why we’ve made it our vision to improve global healthcare with reliable, fast and easy patient diagnoses.
Want to know more about our mission and vision? Click on the link:Link of YouTube video
Our people At Radiometer, we acknowledge that the information our products provide is often the difference between life and death; an acknowledgement that drives and unites us as a company. From biotech and software specialists to financial controllers and engineers, all 3200 colleagues are committed and dedicated to help realize life’s potential.
If you aspire to be part of a purpose, performance and values driven organization whose mission and vision guide every action, we are eager to hear from you.
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 to provide clinical evidence to prove safety and performance of our devices. Radiometer has a diverse and technologically advanced line of Medical Devices that is used for diagnosing a broad group of patients worldwide. This job allows you to generate clinical evidence for our products which help make diagnostic decisions that save lives.
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 be a key contributor internally when you communicate the progress of clinical studies and conclude on the analysis data.
Join the Clinical and Medical Affairs Team You join our Clinical and Medical Affairs Team, who has a large impact on the business as they:
•Provide clinical and scientific knowledge and expertise across all business areas •Provide strategic direction to support timely development and execution of the clinical program •Externally lead scientific discussions with regulatory agencies, investigators and external experts •Partner cross functionally to provide and collect critical input for evidence generation to support regulatory submissions, clinical evaluations and overall evidence and support across all business areas and across the product lifecycle •Lead pre-market medical activities to ensure successful launch
*Responsibilities * You can expect to: •Lead the development and execution of the clinical evidence portfolio for multiple programs, ensuring that global market needs are designed into the overall clinical study trial plans (pre-market and post-market) •Proactively identify clinical project risks, provide input to appropriate counter-measures and contingency plans while assuring implementation of action plans to reduce project risk •Represent the Sponsor in clinical study planning, study design, study execution and study closeout. Examples of deliverables include clinical evidence strategy plan, clinical protocol, monitoring plan and clinical report •Deliver study site qualification, site selection, site initiation, review of clinical study monitoring, evaluation of clinical results, report generation and clinical evidence publication of trial results in peer-reviewed journals •Participate in core teams as the representative from Clinical Affairs and on a daily basis proactively lead study execution within budget along with your Clinical peers.
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.
Contribute, grow and develop Radiometer is a growing organization always developing through LEAN management tools and values. It makes it fun and meaningful to be part of an organization where your thoughts and ideas are embraced by management and can make a true impact. 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.
Application deadline Application deadline is Monday 18 June 2018, but we will interview as soon as we identify relevant candidates. Please start the application process as soon as possible by pressing "Apply Online". Please attach your CV and other relevant documents. We look forward to receiving your application. For further information, please contact Hiring Manager, Susanne Faarbæk at tel. 45 5167 6133.
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:
•You have more than 5 years of experience in leading clinical study execution as a Clinical Study Manager •You understand how to apply your clinical development expertise to create excellent clinical plans and you can inspire trust and respect among your international colleagues •You have demonstrated experience with successful proactive planning and leading clinical study execution for clinical diagnostics and/or medical devices in a regulated environment •You have demonstrated a solid track record of successful results and in leading collaboration in effective teams and getting work done through others •You have demonstrated strong ability to understand complex scientific, engineering and business concepts
On a personal level you are positv, energetic, structured and organized combined with a high level of ethical standards.
Danaher Corporation Overview
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 62,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $16.9B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,300% over 20 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Job Function: Science
Primary Location: EMEA-Western Europe-Denmark-Hovedstaden-Brønshøj
Req ID: MED001542