Senior Clinical Research Specialist
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Ballerup
Do you have a passion for working with clinical documentation and clinical investigations? Are you able to take responsibility for the strategic direction of how we work to document our medical devices? And do you want to join a successful company in rapid growth? Then we have an exciting job opportunity that may be your next career move…
At Ambu, we develop, produce and sell medical devices, which enable doctors and nurses to save lives and improve patient care. We are currently experiencing massive success and due to the internal career advancement of one of your future colleagues, we are looking for a Senior Clinical Research Specialist.
You will join the growing Global Clinical Affairs department divided into: Clinical Research, Post Market Clinical Development, Clinical Operations and Biosafety. Most of us are based at Ambu Headquarters in Ballerup, Denmark, but we also have colleagues based at our site in Malaysia, in Germany, and in the Clinical Operation department under establishment in the US. As Senior Clinical Research Specialist you will participate in securing our ongoing dedication to quality products and will report to Head of Clinical Research located in Ballerup.
Key Responsibilities:
As Senior Clinical Research Specialist you have responsibility for clinical documentation aspects of your assigned project(s). Your primary project deliveries are the CEP, CDP, & CER.
Your main responsibilities include:
An expert in clinical medical device sector
You have experience in planning and execution of clinical investigations and Post Market Clinical Follow-up activities in accordance with relevant regulations eg. MDR, FDA. You set the bar for the right clinical documentation level with a risk-based approach and in line with the rest of clinical team. Additionally, you are highly experienced in writing and reviewing scientific documentation and an expert in regulations and guidelines related to clinical device documentation.
As a person, you act as a champion for change and you take the ownership for following through on changes. You are an efficient communicator and you are a good networker as this will help you to succeed in the job. Additionally, you make accurate judgements and decisions and you drive continuous improvement.
Finally, you need to have excellent command of the English language, as this will be your main working language, both in speech and in writing.
Ambu – a visionary and international workplace where your efforts matter
Ambu is a company that expands rapidly and has ambitious growth targets. We meet these targets through interdisciplinary teamwork between motivated and highly skilled employees. Your contributions and efforts are crucial to our success and by joining us you will get the opportunity to work in an international head office with an informal working environment.
We offer a wide range of professional, social and financial employee benefits along with exciting job challenges and career opportunities contributing to your job satisfaction.
When to apply
If you are ready to apply for the position, please apply as soon as possible. We will invite candidates for interviews on a continuous basis so no need to hesitate. This job ad might be online until 10 July 2020, but once we have found the right candidate, this ad will no longer be online.
For further inquiries please contact Head of Clinical Research, Daniel Carter at +45 7225 2190
Your application will be treated confidentially.
About Ambu
Since 1937, breakthrough ideas have fuelled our work on bringing efficient healthcare solutions to life. This is what we create within our fields of excellence – Anaesthesia, Patient Monitoring & Diagnostics, and Emergency Care. Millions of patients and healthcare professionals worldwide depend on the functionality and performance of our products. We are dedicated to improve patient safety and determined to advance single-use devices. The manifestations of our efforts range from early inventions like the Ambu Bag™ resuscitator and the legendary BlueSensor™ electrodes to our newest landmark solutions like the Ambu aScope™ – the world’s first single-use flexible endoscope. Our commitment to bringing new ideas and superior service to our customers has made Ambu one of the most recognized medical companies in the world. Headquartered near Copenhagen in Denmark, Ambu employs approximately 3,500 people in Europe, North America and the Asia Pacific. For more information, please visit www.Ambu.com
At Ambu, we develop, produce and sell medical devices, which enable doctors and nurses to save lives and improve patient care. We are currently experiencing massive success and due to the internal career advancement of one of your future colleagues, we are looking for a Senior Clinical Research Specialist.
You will join the growing Global Clinical Affairs department divided into: Clinical Research, Post Market Clinical Development, Clinical Operations and Biosafety. Most of us are based at Ambu Headquarters in Ballerup, Denmark, but we also have colleagues based at our site in Malaysia, in Germany, and in the Clinical Operation department under establishment in the US. As Senior Clinical Research Specialist you will participate in securing our ongoing dedication to quality products and will report to Head of Clinical Research located in Ballerup.
Key Responsibilities:
As Senior Clinical Research Specialist you have responsibility for clinical documentation aspects of your assigned project(s). Your primary project deliveries are the CEP, CDP, & CER.
Your main responsibilities include:
- Strategic responsibility within the clinical area and active sparring partner in development projects and improvement projects
- Collaborate with development engineers, clinical application specialists and external healthcare professionals to run use simulations
- Write and review clinical medical device documentation
- Plan and execute clinical evaluation and investigation activities
An expert in clinical medical device sector
You have experience in planning and execution of clinical investigations and Post Market Clinical Follow-up activities in accordance with relevant regulations eg. MDR, FDA. You set the bar for the right clinical documentation level with a risk-based approach and in line with the rest of clinical team. Additionally, you are highly experienced in writing and reviewing scientific documentation and an expert in regulations and guidelines related to clinical device documentation.
As a person, you act as a champion for change and you take the ownership for following through on changes. You are an efficient communicator and you are a good networker as this will help you to succeed in the job. Additionally, you make accurate judgements and decisions and you drive continuous improvement.
Finally, you need to have excellent command of the English language, as this will be your main working language, both in speech and in writing.
Ambu – a visionary and international workplace where your efforts matter
Ambu is a company that expands rapidly and has ambitious growth targets. We meet these targets through interdisciplinary teamwork between motivated and highly skilled employees. Your contributions and efforts are crucial to our success and by joining us you will get the opportunity to work in an international head office with an informal working environment.
We offer a wide range of professional, social and financial employee benefits along with exciting job challenges and career opportunities contributing to your job satisfaction.
When to apply
If you are ready to apply for the position, please apply as soon as possible. We will invite candidates for interviews on a continuous basis so no need to hesitate. This job ad might be online until 10 July 2020, but once we have found the right candidate, this ad will no longer be online.
For further inquiries please contact Head of Clinical Research, Daniel Carter at +45 7225 2190
Your application will be treated confidentially.
About Ambu
Since 1937, breakthrough ideas have fuelled our work on bringing efficient healthcare solutions to life. This is what we create within our fields of excellence – Anaesthesia, Patient Monitoring & Diagnostics, and Emergency Care. Millions of patients and healthcare professionals worldwide depend on the functionality and performance of our products. We are dedicated to improve patient safety and determined to advance single-use devices. The manifestations of our efforts range from early inventions like the Ambu Bag™ resuscitator and the legendary BlueSensor™ electrodes to our newest landmark solutions like the Ambu aScope™ – the world’s first single-use flexible endoscope. Our commitment to bringing new ideas and superior service to our customers has made Ambu one of the most recognized medical companies in the world. Headquartered near Copenhagen in Denmark, Ambu employs approximately 3,500 people in Europe, North America and the Asia Pacific. For more information, please visit www.Ambu.com
Information og data
Denne ledige stilling har jobtypen "Forsker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 11.6.2020, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Forsker
- Ballerup
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