Chen Woldner
Chemical Engineer- Clinical Trials Manager
Summary
Having a B.Sc in Chemical Engineering. Highly skilled multidisciplinary project manager with experience in clinical trials at the pharmaceutical industry. Knowledge of global and local regulations. Highly motivated, action oriented, persistent and drives for success. A team player with good communication skills.
Overview
4
4
years of post-secondary education
2
2
Languages
Work History
Clinical Trials Manager
Dexcel Pharma Technologies Ltd.
2016 - Current
- Managing various multi-center and single-center trials locally and globally while adhering to ICH-GCP guidelines.
- Responsibilities from study design through feasibility, site selection and start-up, negotiation and contracts, site initiation visits, interim monitoring visits and close out visits.
- Supported sites with source data verification, query resolution, drug dispensing and accountability, paper and e-CRF review, TMF review.
- Protocol and ICF writing, study documents completion and submission to local and global Health Authorities and ECs
- Statistical evaluation of study results
- Vendor’s management
- Knowledge of global and local regulations and standards such as GCP, GMP, FDA, EMA and Israeli MOH.
- Followed informed consent processes and maintained records
Clinical Trials & PV QA
Dexcel Pharma Technologies Ltd.
2014 - 2016
- Compliance of clinical trials, bioanalytical Lab and PV department by auditing, investigation of failures and finding root causes and CAPA.
Quality assurance Manager Assistant
Inter Electric Industries Ltd.
2012 - 2013
- SOP writing.
Education
Bachelor of Science - Chemical Engineering
Technion Israel Institute of Technology
01.2009 - 01.2013
Military Service
IDF- Teleprocessing Corps, Training officer & platoon officer of basic signal courses, The position required high training skills and leadership.
Publications
"Donnan Dialysis" ("Simple Model for Characterizing a Donnan Dialysis Process" by David Hasson,*,† Adam Beck,‡ Fiana
Fingerman,† Chen Tachman,† Hilla Shemer,† and Raphael Semiat†), 2014.
Timeline
Bachelor of Science - Chemical Engineering
Technion Israel Institute of Technology
01.2009 - 01.2013
Clinical Trials Manager
Dexcel Pharma Technologies Ltd.
2016 - Current
Clinical Trials & PV QA
Dexcel Pharma Technologies Ltd.
2014 - 2016
Quality assurance Manager Assistant
Inter Electric Industries Ltd.
2012 - 2013
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