QA Clinical Trials
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Kongens Lyngby
At MedTrace you will be a valued member of the team and take part in our exciting journey of bringing our innovative soft and hardware solution for heart patient diagnostics to market. The technology is ground breaking and is already now drawing international accreditation.
MedTrace’s technology platform is a combination of an automated hardware system that is able to produce, dose and inject 15O-water, a very short-lived radioactive version of regular water and a software solution that makes the clinician able to draw conclusions about blood flow. The technique has potential for use in other organs and for diagnostic use in other diseases.
MedTrace has offices in Lyngby, Denmark and affiliates in Boston and Uppsala. The company favours cross functional teamwork and hiring employees with diverse backgrounds. The company language is English. In MedTrace, all members are valued, we are all very dedicated and ambitious in reaching our common goals. Every day presents itself with plenty of exciting tasks, but we are high spirited with a good sense of HUMOR. The atmosphere is informal, and everybody in the team is heard. Our values include trust in each other, respect for people, responsibility and dedication.
To become a success at MedTrace it is important to have an entrepreneurial mindset with a pragmatic approach to manoeuvre in a young organisation. The targeted markets are Europe, the US and later on Japan.
The position as QA Clinical Trials
The position as QA Clinical Trials is new at MedTrace. You will get an exciting opportunity to exercise your knowledge within quality assurance in various technical areas such as medical device, pharmaceuticals, hardware, software, etc. but also in your work around the collaboration with external partners who conduct clinical studies.
Your role will be to be the connection between external CRO companies doing clinical trials for Medtrace and you are expected to have an eye on how the studies are performing in terms of inclusion and performance, any quality issues and how is that mirrored in the protocol and in the QA system. Your task will also be to ensure issues are described in the QMS system.
You will be stepping into the design and development phase of MedTrace´s products, so being able to execute on tasks in an efficient manner is key to your success. Your main base of operation will be at head office in Lyngby Copenhagen, and MedTrace is flexible towards working from home. You must expect some travelling in accordance with site visits.
Profile
Your key responsibilities will be:
Background
Your background is M. Sc. in the life science field/Pharmacist or similar relevant education. As a minimum you have 3 years of work experience with quality assurance including experience with clinical trials. Your experience also covers knowledge of the operational aspects in the setup and monitoring of clinical sites.
Other qualifications:
You thrive in the innovative environment that a development stage company can offer.
Personal profile
You are a “doer”. The company pulse is intense, but together we can accomplish almost everything. You want to make a difference and have an impact, and you like to see your input and ideas transformed into action swiftly. As a person you can simplify things, find solutions, and work collaborative. You are a responsible person, and you excel in maintaining focus even in busy times. You are a trustworthy person, and you value to get things done to a high quality level.
Application
For more information, please contact Lise Sønnersgaard, Recruitment manager at PharmaRelations, telephone +45 60981303 or [email protected]. We will evaluate applications on a running basis, but we need your application no later than June the 14th 2021.
You can apply here:
MedTrace’s technology platform is a combination of an automated hardware system that is able to produce, dose and inject 15O-water, a very short-lived radioactive version of regular water and a software solution that makes the clinician able to draw conclusions about blood flow. The technique has potential for use in other organs and for diagnostic use in other diseases.
MedTrace has offices in Lyngby, Denmark and affiliates in Boston and Uppsala. The company favours cross functional teamwork and hiring employees with diverse backgrounds. The company language is English. In MedTrace, all members are valued, we are all very dedicated and ambitious in reaching our common goals. Every day presents itself with plenty of exciting tasks, but we are high spirited with a good sense of HUMOR. The atmosphere is informal, and everybody in the team is heard. Our values include trust in each other, respect for people, responsibility and dedication.
To become a success at MedTrace it is important to have an entrepreneurial mindset with a pragmatic approach to manoeuvre in a young organisation. The targeted markets are Europe, the US and later on Japan.
The position as QA Clinical Trials
The position as QA Clinical Trials is new at MedTrace. You will get an exciting opportunity to exercise your knowledge within quality assurance in various technical areas such as medical device, pharmaceuticals, hardware, software, etc. but also in your work around the collaboration with external partners who conduct clinical studies.
Your role will be to be the connection between external CRO companies doing clinical trials for Medtrace and you are expected to have an eye on how the studies are performing in terms of inclusion and performance, any quality issues and how is that mirrored in the protocol and in the QA system. Your task will also be to ensure issues are described in the QMS system.
You will be stepping into the design and development phase of MedTrace´s products, so being able to execute on tasks in an efficient manner is key to your success. Your main base of operation will be at head office in Lyngby Copenhagen, and MedTrace is flexible towards working from home. You must expect some travelling in accordance with site visits.
Profile
Your key responsibilities will be:
- Ensure centralized monitoring in accordance with SOPs, regulations and guidelines.
- Monitor and document the Company’s clinical trial activities including trial design and protocol preparation.
- Interact with clinical stakeholders and internal resources during clinical trial preparation and execution.
- Ensure that clinical trial products are properly labelled and made available to the trial sites.
- Review and oversee the data collection throughout the trial.
- Participate in the continuous improvement of the function’s procedures to secure best practices.
Background
Your background is M. Sc. in the life science field/Pharmacist or similar relevant education. As a minimum you have 3 years of work experience with quality assurance including experience with clinical trials. Your experience also covers knowledge of the operational aspects in the setup and monitoring of clinical sites.
Other qualifications:
- Experience with Quality Management System(s)
- Knowledge of ISO 13485
- Knowledge of pharmaceutical legislation and GMP
- Experience with clinical trial management inclusive protocols/reports
- Experience with supply chain management, in particular clinical trials
- Good understanding of medical terminology and science associated with development of medicines
- Strong in collaborative thinking and capability
- Able to work independently
- Speaks and writes English fluently and profound IT skills in MS Office package
- Strong in oral as well as written communication capabilities
You thrive in the innovative environment that a development stage company can offer.
Personal profile
You are a “doer”. The company pulse is intense, but together we can accomplish almost everything. You want to make a difference and have an impact, and you like to see your input and ideas transformed into action swiftly. As a person you can simplify things, find solutions, and work collaborative. You are a responsible person, and you excel in maintaining focus even in busy times. You are a trustworthy person, and you value to get things done to a high quality level.
Application
For more information, please contact Lise Sønnersgaard, Recruitment manager at PharmaRelations, telephone +45 60981303 or [email protected]. We will evaluate applications on a running basis, but we need your application no later than June the 14th 2021.
You can apply here:
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Kongens Lyngby.
Jobbet er oprettet på vores service den 28.5.2021, 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.
- Øvrige
- Kongens Lyngby
- Onsdag den 16. juni 2021
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