Clinical Trial Manager In-vitro Diagnostik
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Kongens Lyngby
PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialise in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders.
We are currently partnering with SSI Diagnostica and their R&D unit. They are looking to recruit a Clinical Trial Manager-IVD to join their internal R&D team in Copenhagen, Denmark. The position is office based, full-time and up to at least 30 days travel must be except.
As a Clinical Trial Manager, you will be responsible for the establishment of relevant network among external hospital KOL & PI, including WHO and FIND network. Writing the clinical protocols and ensure site relevance, is of essence. You have knowledge from medical devices and are familiar with design control, verification, and validation phase. Support and share knowledge with the commercial department e.g. tender input, educational workshops for distribution partners and direct customers. You are happy to make written reports, documentation and analyze clinical data for commercial purpose. Your participation and active involvement in R&D activities and projects is very important, hence this position gives you a great opportunity to influence the R&D department and SSI Diagnostics future
Key responsibilities include:
Requirements:
Why?
SSI Diagnostica, which until 2016 was part of Statens Serum Institut, has in recent years been in a build-up phase, especially in international markets. To further accelerate its growth, SSI Diagnostica have acquiring the American company CTK Biotech, which, among other things, has developed one of the world's most accurate COVID-19 antibody tests to date. With the acquisition, SSI Diagnostica strengthens its global production and distribution and gains access to a wide range of new markets around the world.
Clinical studies within in-vitro diagnostics is a requirement according to IVDR and can furthermore be the gamechanger for winning the sales. SSI Diagnostica will be responsible of Clinical studies across the SSI Diagnostica Group (SSI Diagnostica and CTK Biotech).
How?
For further information do reach out to Head of recruitment Ida Wenger- Parving on +45 2633 4301or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience.
At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, color, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.
We are currently partnering with SSI Diagnostica and their R&D unit. They are looking to recruit a Clinical Trial Manager-IVD to join their internal R&D team in Copenhagen, Denmark. The position is office based, full-time and up to at least 30 days travel must be except.
As a Clinical Trial Manager, you will be responsible for the establishment of relevant network among external hospital KOL & PI, including WHO and FIND network. Writing the clinical protocols and ensure site relevance, is of essence. You have knowledge from medical devices and are familiar with design control, verification, and validation phase. Support and share knowledge with the commercial department e.g. tender input, educational workshops for distribution partners and direct customers. You are happy to make written reports, documentation and analyze clinical data for commercial purpose. Your participation and active involvement in R&D activities and projects is very important, hence this position gives you a great opportunity to influence the R&D department and SSI Diagnostics future
Key responsibilities include:
- Establish relevant KOL network at interested global site
- Facilitate workshops and educational seminars on products.
- Ensure Clinical trials and monitoring.
- Ensure the correct documentation, write report and medical writing.
- Ensure compliance to IVDR (EU-legislation 2017/746), ISO 13485
- Participate in Post market surveillance activities
Requirements:
- Master degree within Sciences
- +5 years’ experience with Clinical trial International- preferable in-vitro diagnostic
- Strong communication and presentation skills
- Stakeholder management and network skills
- Project leader experience
- Solid understanding of R&D process
- Solid understanding of and experience from ISO 13485, cGMP and extra valuable if you have knowledge of IVDR
- Positive with a can-do attitude
- Independent but team player
Why?
SSI Diagnostica, which until 2016 was part of Statens Serum Institut, has in recent years been in a build-up phase, especially in international markets. To further accelerate its growth, SSI Diagnostica have acquiring the American company CTK Biotech, which, among other things, has developed one of the world's most accurate COVID-19 antibody tests to date. With the acquisition, SSI Diagnostica strengthens its global production and distribution and gains access to a wide range of new markets around the world.
Clinical studies within in-vitro diagnostics is a requirement according to IVDR and can furthermore be the gamechanger for winning the sales. SSI Diagnostica will be responsible of Clinical studies across the SSI Diagnostica Group (SSI Diagnostica and CTK Biotech).
How?
For further information do reach out to Head of recruitment Ida Wenger- Parving on +45 2633 4301or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience.
At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, color, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.
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 28.4.2021, 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
- Fredag den 14. maj 2021
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