Clinical Affairs Specialist
CellaVision AB / Apotekarjobb / Lund
2017-01-23
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CellaVision is an innovative, global medical technology company that develops and sells its own leading systems for routine analysis of blood and other body fluids in health care services. The analyses often constitute important reference data for fast and correct diagnosis of illnesses such as viral and bacterial infections and cancers. CellaVision's products rationalize manual laboratory work, and secure and support effective workflows and skills development within and between hospitals. The company has leading-edge expertise in image analysis, artificial intelligence and automated microscopy. In 2015 sales were SEK 239 million. Sales continue to increase, with a growth target of at least 15 % per year over an economic cycle. CellaVision's registered office is in Lund, Sweden and the company has subsidiaries in the USA, Canada, Japan, Republic of Korea and Dubai. The share is listed on the OMX Stockholm, Small Cap list. Read more at
www.cellavision.comCellaVision is strengthening the team with a Clinical Affairs Specialist. The main duty for the position will be to facilitate studies in both non-clinical and clinical phases, as well as the pre- and post-market studies. You will also be an active part in interacting with internal experts/sponsors in product related projects. The organizational place for this position is in the Quality department and you will report to the Clinical Affairs Manager.
Responsibilities
Plan, design, initiate and coordinate clinical studies together with CRM.
Establish and maintain professional relationships (in person, by phone and/or email) with hospital laboratories and distributors as necessary to support clinical studies.
Monitor that assigned clinical studies are in compliance with all applicable regulations and company procedures. Such studies include the pre-clinical and clinical phases, as well as the pre- and post-market studies; they also include specific trials run to obtain FDA approval for the United States market.
Process data from clinical studies, including but not limited to analysis, interpretation and compilation.
Interact with all departments at CellaVision as well as directly interact with investigators at international level.
Take part in pre-submission meetings with for example the FDA regarding clinical study design.
Requirements
Academic degree BSc in Science with experience of working in a laboratory environment preferable hematology.
Experience of clinical studies related to medical device, preferably IVD or experience of working in a controlled laboratory environment.
Excellent understanding, or ability to quickly develop the same, of user needs and regulatory requirements.
Qualifications
We believe that you have strong organizational and project management skills and excellent oral and written communication skills. You like to work independently, prioritizing your work tasks in a sufficient manner and you have an outgoing, energetic and result oriented hands-on personality.
Furthermore, you possess the ability to work with several projects and activities at the same time. Your computer skills are excellent and high in common Microsoft Office Environment.
Travelling requirements
You will have approximately 20 to 40 traveling days yearly.
Contact and application
If you are interested in becoming part of our progressive and innovative company, please contact us. For more information about this position please contact recruiting manager Karin Hannander, Manager Clinical Affairs, by e-mail:
karin.hannander@cellavision.com To apply for this position, please click on Apply and submit your application and résumé, no later than 6/2 2017.
Varaktighet, arbetstid
Heltid Anställningstid enligt överenskommelse
Publiceringsdatum2017-01-23Ersättning Lön enligt överenskommelse
Så ansöker duSista dag att ansöka är 2017-07-12
Klicka på denna länk för att göra din ansökanKontaktKarin Hannander
karin.hannander@cellavision.comFöretagCellaVision AB
AdressCellaVision AB
Scheelevägen 19
22370 Lund
KontorsadressScheelevägen 19, Lund
Jobbnummer 3276313
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