susanne zdroik

associate director translational sciences

Country

switzerland

City

basel

Industry

pharmaceuticals

Skill

clinical trials, clinical research, gcp, drug development, asthma, clinical pharmacology, ich gcp, protocol, sop, pharmaceutical industry, ctms, clinical study design, regulatory submissions, clinical development, clinical trial management, project management, oncology, life sciences, good clinical practice, clinical trial management system, urology, cro management, electronic data capture, vendor management, cross functional team leadership, intercultural awareness, english

Experience

associate director translational sciences

teva pharmaceuticals

2019-4 - Present · 7 yrs 6 mos

global trial leader

novartis

2013-1 - 2014-11 · 1 yr 11 mos

senior international clinical trial manager

ferring pharmaceuticals

2008-11 - 2012-12 · 4 yrs 2 mos

international clinical trial manager

ferring pharmaceuticals

2006-1 - 2008-10 · 2 yrs 10 mos

* Responsible for clinical pharmacology studies (phase I-IIa) covering planning, initiating, running and reporting of a clinical study. The work included e.g. the following tasks: * Lead and optimise the performance of study teams * Initiate contacts and liase with internal and external partners * CRO selection and initiation * Forecast, track and manage study timelines, budget and resources * Authoring of study documents e.g. clinical study protocol

global clinical quality assurance auditor

astrazeneca r&d

2003-10 - 2005-12 · 2 yrs 3 mos

* Responsible for Clinical quality assurance activities incl. * Develop audit programs and coordinate audits for assigned trials and * projects * Plan, conduct and report investigator site, document and study file audits * Communicate audit findings and improvement recommendations to project * team * Prepare compliance statements

clinical study leader

astrazeneca r&d

2000-8 - 2003-9 · 3 yrs 2 mos

* Responsible for in total 3 phase III studies with Symbicort in asthma covering planning, initiating, running and reporting of a clinical study. The work included e.g. the following tasks: * Lead and optimise the performance of study teams * Initiate contacts and liase with internal and external partners * Forecast, track and manage study timelines, budget and resources * Plan and lead investigators’ meeting * Plan and lead monitors’ and data managers’ meeting * Authoring of study documents e.g. clinical study protocol and report

clinical research associate

searle scandinavia

1998-2 - 2000-8 · 2 yrs 7 mos

* Responsible for the local activities of global clinical studies incl. * Communication with ethics committees and regulatory authorities * Investigator site selection and initiation * Agreements with investigators, pharmacies and other partners * Monitoring incl source data verification * Managing the local study master file