
Puk Stewart
I have worked in the area of clinical research since 1996. I originally joined a Phase I unit... | Copenhagen, Copenhagen, Denmark
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Puk Stewart’s Location Copenhagen, Copenhagen, Denmark
Puk Stewart’s Expertise I have worked in the area of clinical research since 1996. I originally joined a Phase I unit as a multi-skilled Medical Laboratory Scientific Officer (MLSO) I/II, where I later accepted a job as an assistant project manager. Since then I have worked as a CRA and SCRA in various positions stretching from Phase I (including Proof of Concept studies and FIM studies) to Phase III, during the majority of my time as CRA and SCRA I was involved in study start up, from protocol synopsis stage to site initiation and Interim Monitoring. I continued into Study Management first as Senior Associate Global Clinical Research Management (junior Study Manager) where I worked on global phase III oncology studies through the primary analysis and the database locks and into Open Label Extension, before finally being full time on the European clinical part of the Inspection Readiness programmes Secondly, as a Temporary Clinical Scientist (Study Manager) where I was managing CROs and co-monitor phase I to III studies. I have also worked as CRA line manager for a group of CRAs in Denmark for approximately 1 1/2 years, and in Global Study Management as Process Manager for 3 years. Additionally I have been National lead CRA with sponsor oversight responsibilities for phase I-IV trials, and Feasibility lead in a Pharmaceutical company. Clinical trial oversight lead and I am currently a GCP advisor specialist focusing on phase I unit selection, being the clinical pharmacology quality partner and sponsor oversight. From 1996 to November 2010 I was based in the UK, but in November 2010 I relocated to Denmark. Specialties: GCP, QC, problem solving, Phase I, Feasibility and sponsor trial oversight
Puk Stewart’s Current Industry Novo Nordisk
Puk
Stewart’s Prior Industry
Gdru
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Msd
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Ge Healthcare
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Celgene
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Amgen
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Neurosearch
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Norma
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H Lundbeck
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Inventiv Health Clinical
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Leo Pharma
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Alnylam Pharmaceuticals
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Novo Nordisk
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Work Experience

Novo Nordisk
GCP Advisor Specialist
Tue Jun 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Alnylam Pharmaceuticals
Senior clinical trial oversight lead
Thu Aug 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Jun 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Leo Pharma
Feasibility Lead
Sat Dec 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Aug 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Leo Pharma
Senior Clinical Research Associate
Wed Feb 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Dec 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Inventiv Health Clinical
International Clinical Trials Manager/Senior Clinical Research Associate @ Leo Pharma
Tue Sep 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Dec 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)
H Lundbeck
Process Manager
Sat Dec 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Dec 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time)
Norma
CRA Line Manager
Mon Aug 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Dec 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time)
Neurosearch
Clinical Trial Manager
Mon Nov 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jul 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time)
Amgen
Senior Associate
Thu Jan 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Nov 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time)
Celgene
Senior CRA
Fri Jun 01 2007 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Dec 01 2008 00:00:00 GMT+0000 (Coordinated Universal Time)
Ge Healthcare
CRA
Fri Aug 01 2003 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Dec 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time)
Msd
Clinical Research Associate
Mon Jan 01 2001 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Jan 01 2003 00:00:00 GMT+0000 (Coordinated Universal Time)
Gdru
assistant pm
Mon Jan 01 1996 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jan 01 2001 00:00:00 GMT+0000 (Coordinated Universal Time)