sa Bandholtz Email & Phone Number | Graduated in Uppsala, in Biotechnology and was granted Erasmus scholarship so studied Medical Microbiology for a year in New Castle upon Tyne. I then got a PhD- position at Karolinska Institute, in Gene Therapy, and stayed for five years. I was also a teacher at Södertörns Högskola as part of the PhD program. I held a course in Functional Genomics for the University students at Södertörn. My interest for clinical trials started when I took a course in Clinical Drug development (CDD course) in 2005. Joined the CRO company Parexel and worked as Clinical trial specialist and then shortly joined another CRO, Icon. At Icon I was a country specialist working with submission for Sweden and Norway close collaboration with site/s and CRA/s as well as communicated with different sponsors. Worked with contracts for 2 years as part of the activation of site/s. Mentored junior staff and new beginners in the team. In 2014 I joined Inventiv Health (now Syneos Health) and continued working with submissions but now also in Denmark and Finland. Subject matter expert of Norway and Sweden and also participates in monthly review’s of regulatory updates as well as reporting of any changes in law and regulations. Support managers with all kinds of information about the Nordics countries from local requirements but also more tricky questions from a regulatory point of view in clinical trials. The last years I have taken on a more defined mentor role for junior staff but also supporterd more experienced colleagues. I was highly involved in the process of understanding how to handle clinical studies in Norway and Sweden under the start of pandemic. The last couple of months I have been participating in Syneos EU CTR initiative and held trainings for the Nordic team on the new EU regulation. Also train our Nordic team with various items, such as new SOP’s, Regulatory green light (RGL) requirements, calculation of timelines for submission and approvals both under EU CTD and EU CTR, tracking in various systems and filing procedures. Been trained in line management tasks such as a deeper understanding of project delivery in a timely manner, time reporting, RGL projections and GRM. Recently prepared a budget for Norway to be used when calculation to be made for time spent per task. A rather detailed description of my years within different CRO’ s and knowledge gained. July 2022 I started a position as Clinical Operation manager at FSP Syneos Health. Now 5 months later I am very grateful for the job opportuinty and the possibilty to work with such an excellent team.

sa Bandholtz

Graduated in Uppsala, in Biotechnology and was granted Erasmus scholarship so studied Medical Microb...
Greater Stockholm Metropolitan Area, Greater Stockholm Metropolitan Area, Sweden

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sa Bandholtz’s Email asa.bandholtz@crc.ki.se

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sa Bandholtz’s Location Greater Stockholm Metropolitan Area, Greater Stockholm Metropolitan Area, Sweden

sa Bandholtz’s Current Industry Syneos Health

sa Bandholtz’s Prior Industry Icon Clinical Research | Parexel | Icelandic Herbs | Karolinska Institute

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Work Experience

Syneos Health

Nordic & Baltics Manager Clinical Operations

2022-07-01 00:00:00 - Present

Icon Clinical Research

Study Start Up Associate

2008-10-01 00:00:00 - 2016-01-01 00:00:00

Parexel

Clinical trial specialist

2007-09-01 00:00:00 - 2008-01-01 00:00:00

Icelandic Herbs

Seller-and product specialist

2002-02-01 00:00:00 - 2003-01-01 00:00:00

Karolinska Institute

PhD-student

1997-09-01 00:00:00 - 2002-01-01 00:00:00

Skills

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FAQ About sa Bandholtz

sa Bandholtz is located at
Greater Stockholm Metropolitan Area, Greater Stockholm Metropolitan Area, Sweden

sa Bandholtz is a Graduated in Uppsala, in Biotechnology and was granted Erasmus scholarship so studied Medical Microbiology for a year in New Castle upon Tyne. I then got a PhD- position at Karolinska Institute, in Gene Therapy, and stayed for five years. I was also a teacher at Södertörns Högskola as part of the PhD program. I held a course in Functional Genomics for the University students at Södertörn. My interest for clinical trials started when I took a course in Clinical Drug development (CDD course) in 2005. Joined the CRO company Parexel and worked as Clinical trial specialist and then shortly joined another CRO, Icon. At Icon I was a country specialist working with submission for Sweden and Norway close collaboration with site/s and CRA/s as well as communicated with different sponsors. Worked with contracts for 2 years as part of the activation of site/s. Mentored junior staff and new beginners in the team. In 2014 I joined Inventiv Health (now Syneos Health) and continued working with submissions but now also in Denmark and Finland. Subject matter expert of Norway and Sweden and also participates in monthly review’s of regulatory updates as well as reporting of any changes in law and regulations. Support managers with all kinds of information about the Nordics countries from local requirements but also more tricky questions from a regulatory point of view in clinical trials. The last years I have taken on a more defined mentor role for junior staff but also supporterd more experienced colleagues. I was highly involved in the process of understanding how to handle clinical studies in Norway and Sweden under the start of pandemic. The last couple of months I have been participating in Syneos EU CTR initiative and held trainings for the Nordic team on the new EU regulation. Also train our Nordic team with various items, such as new SOP’s, Regulatory green light (RGL) requirements, calculation of timelines for submission and approvals both under EU CTD and EU CTR, tracking in various systems and filing procedures. Been trained in line management tasks such as a deeper understanding of project delivery in a timely manner, time reporting, RGL projections and GRM. Recently prepared a budget for Norway to be used when calculation to be made for time spent per task. A rather detailed description of my years within different CRO’ s and knowledge gained. July 2022 I started a position as Clinical Operation manager at FSP Syneos Health. Now 5 months later I am very grateful for the job opportuinty and the possibilty to work with such an excellent team.