2013 -
2017 Senior Compliance and Process Specialist @
now Copenhagen @
now Maintenance and development of Clinical R and D SOPs
Managing Public Disclosure processes of clinical trials
Surveillance and implementation of legislative changes
GCP Compliance and improvement of GCP processes @
2008 -
2010 GCP Advisor and Global Clinical Compliance Manager @
2005 -
2008 GCP Auditor and GCP Auditor Specialist, System and Processes @
1998 -
2001 Clinical Research Associate @
1996 -
1997 Clinical Research Nurse @ Copenhagen University Hospital,
2012 -
2013 Compliance and Process Specialist @
2010 -
2012 Process and Training Manager @
2001 -
2005 International Clinical Trial Coordinator at H. Lundbeck A and S @
1997 -
1998 Clinical Research Associate @ Quintiles AB
1986 -
1996 Reg. Nurse ( Specialised in Oncology) @ Finsen Centre, Copenhagen University Hospital
Lene Bach Education
Reg. nurse
Bachelor's degree (Reg. Nurse, specialised in Oncology)
1983
-
1986
Lene Bach Skills
Clinical Trials
Ich Gcp
CRO
Neurology
GxP
Clinical Research
Clinical Development Processes
Clinical Study Design
Validation
Hematology
Quality Assurance
Clinical Operational Sops
Oncology
Clinical Monitoring
GCP
Drug Development
Clinical Development
Pharmaceutical Industry
Auditing Clinical Processes
FDA
Public Disclosure of Clinical Trials
Sop
21 CFR Part 11
Lene Bach Summary
Lene Bach, based in Copenhagen, DK, is currently a Fratrådt at Fluoguide A/S. Lene Bach brings experience from previous roles at Fluoguide A/S, Genmab, Oncology Venture and Larix A/S. Lene Bach holds a 1983 - 1986 Bachelor's degree in Reg. Nurse, specialised in Oncology @ Reg. nurse. With a robust skill set that includes Clinical Trials, Ich Gcp, CRO, Neurology, GxP and more. Lene Bach has 4 emails on RocketReach.
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