Clinical Research Specialist
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Ballerup
Do you have a passion for working with clinical development, bringing new products to the market fast? Are you able to take responsibility for the strategic direction and completion of the clinical evaluation? Do you want to join a successful company in rapid growth?
Then we have an exciting job opportunity that may be right for you. We are looking for a Clinical Research Specialist to join our Clinical Research team. Our Clinical Research Specialists are core members of each development project team, and a key part of the journey to develop and bring new products to the market.
Clinical Research is part of the Global Clinical Affairs (GCA) department. GCA encompasses both Post Market Clinical Development and Clinical Applications, with whom you will align on understanding the users, and use of the device. We are based at Ambu Headquarters in Ballerup, Denmark, and have clinical colleagues located at our sites in Germany, Malaysia, and the USA. As the successful candidate you will report to Head of Clinical Research.
You will have responsibility for defining the clinical strategy to meet development, regulatory and initial marketing needs within your allocated project(s). You will identify available clinical literature of performance and safety, then navigate any unmet need for new clinical data or other relevant performance data generation. You will conduct and report the clinical evaluation prior to regulatory submissions in the USA and Europe. You will work closely with Design Engineers, RA specialists, QA Engineers and Product Managers to enable you to do so. Expect your first assignments to be within gastrointestinal endoscopy products.
Key Responsibilities:
As Clinical Research Specialist you will have responsibility for clinical documentation aspects of your assigned project(s). Your primary project deliveries are the clinical development plan (CDP), clinical evaluation plan (CEP), and clinical evaluation report (CER). You are also heavily involved in central project decisions and documentation encompassing user needs, use specifications, IFU, clinical claims, and risk management.
Your main responsibilities include:
• Generate state of the art (SoTA) documentation for performance and safety
• Identify the overall clinical scope for the project through defining the clinical benefit we look to achieve, and the resultant clinical strategy to get there
• Generate the CEP including a CDP according to the EU Medical Device Regulation
• Collaborate with internal specialists and external healthcare professionals to run use simulations for clinical development or performance documentation or generate new clinical data as needed
• Conduct and Report the Clinical Evaluation
• Identifying the need for Post Market Clinical Follow-up (PMCF) activities, that your post market clinical colleagues will later deliver.
Experienced in the medical device sector
You have experience in clinical development activities in accordance with European and US regulations. You enjoy navigating the regulations, standards, and guidelines to 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 looking for a position where you can combine your academic skills of reviewing scientific documentation and authoring substantial clinical documents such as CERs, with the interpersonal skills required to efficiently collaborate as a core member of a project team to develop and drive a new product to the market fast.
As a person, you are confident making judgements and decisions, so that you can compromise without being compromised on performance or safety. You are an efficient communicator, good at stakeholder management, and take the ownership for your deliveries. Finally, you have an excellent command of the English language, as this will be your main working language, both in speech and in writing.
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 30th November 2021, 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.
Then we have an exciting job opportunity that may be right for you. We are looking for a Clinical Research Specialist to join our Clinical Research team. Our Clinical Research Specialists are core members of each development project team, and a key part of the journey to develop and bring new products to the market.
Clinical Research is part of the Global Clinical Affairs (GCA) department. GCA encompasses both Post Market Clinical Development and Clinical Applications, with whom you will align on understanding the users, and use of the device. We are based at Ambu Headquarters in Ballerup, Denmark, and have clinical colleagues located at our sites in Germany, Malaysia, and the USA. As the successful candidate you will report to Head of Clinical Research.
You will have responsibility for defining the clinical strategy to meet development, regulatory and initial marketing needs within your allocated project(s). You will identify available clinical literature of performance and safety, then navigate any unmet need for new clinical data or other relevant performance data generation. You will conduct and report the clinical evaluation prior to regulatory submissions in the USA and Europe. You will work closely with Design Engineers, RA specialists, QA Engineers and Product Managers to enable you to do so. Expect your first assignments to be within gastrointestinal endoscopy products.
Key Responsibilities:
As Clinical Research Specialist you will have responsibility for clinical documentation aspects of your assigned project(s). Your primary project deliveries are the clinical development plan (CDP), clinical evaluation plan (CEP), and clinical evaluation report (CER). You are also heavily involved in central project decisions and documentation encompassing user needs, use specifications, IFU, clinical claims, and risk management.
Your main responsibilities include:
• Generate state of the art (SoTA) documentation for performance and safety
• Identify the overall clinical scope for the project through defining the clinical benefit we look to achieve, and the resultant clinical strategy to get there
• Generate the CEP including a CDP according to the EU Medical Device Regulation
• Collaborate with internal specialists and external healthcare professionals to run use simulations for clinical development or performance documentation or generate new clinical data as needed
• Conduct and Report the Clinical Evaluation
• Identifying the need for Post Market Clinical Follow-up (PMCF) activities, that your post market clinical colleagues will later deliver.
Experienced in the medical device sector
You have experience in clinical development activities in accordance with European and US regulations. You enjoy navigating the regulations, standards, and guidelines to 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 looking for a position where you can combine your academic skills of reviewing scientific documentation and authoring substantial clinical documents such as CERs, with the interpersonal skills required to efficiently collaborate as a core member of a project team to develop and drive a new product to the market fast.
As a person, you are confident making judgements and decisions, so that you can compromise without being compromised on performance or safety. You are an efficient communicator, good at stakeholder management, and take the ownership for your deliveries. Finally, you have an excellent command of the English language, as this will be your main working language, both in speech and in writing.
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 30th November 2021, 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.
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 23.3.2021, 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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