CLINICAL TRIAL BUSINESS EXPERT
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- 40764 Langenfeld (Rheinland)
- Weltweit
- de | en
- 22.04.2023
Kurzvorstellung
Qualifikationen
Projekt‐ & Berufserfahrung
8/2015 – 8/2017
Tätigkeitsbeschreibung
Strategic oversight of all global Trial Master File related operations
• Ensuring inspection readiness and Sponsor oversight; development and implementation of quality metrics and QC check guidelines
• Process improvement strategies; overseeing the migration of all studies into one single eTMF management system (Veeva)
• Development & maintenance of TMF SOP, TMF Plan and related business processes
• Manage vendor relationships including CROs in- and outside of the strategic partnering initiative (SPI), eTMF vendors
• Close cooperation with other departments, e.g. Medical Affairs, CQA, Drug Safety, O&C, Regulatory, CTS, CTRRD
• Overseeing archiving and off-site storage of study-related documents at Iron Mountain
• eTMF system training oversight
• Mentoring of TMF Managers and TMF Assistants
• Speaker at the European Trial Master File Congress, 09/2016
• Member of the “Site Leadership Team”
• Member of the “Creative Lab”
Drug Discovery
1/2011 – 7/2015
Tätigkeitsbeschreibung
Planning and conducting clinical trials as Associate Clinical Project Manager
• Implementation of SPI within UCB: streamlining of processes and SOPs with different strategic partners; SOP simplification initiative
• Spot award “silver” for extraordinary contribution to the company by the implementation of SPI
• Implementation of clinical trials from setup to clinical study report
• First contact person for CROs within and outside the scope of SPI
• Close cooperation with other departments, e.g. Medical Affairs, CQA, Drug Safety, O&C, Regulatory, CTS, CTRRD
• Strategic oversight of the entire operational study business
• Global coordination of the clinical site management
• Monitor- and site assessment visit
• Mentoring and training of (lead) CRAs
• Implementation of study requirements within the team, performance and quality control incl. CAPA management
• Ensuring Trial Master File maintenance by (SPI) partners, Sponsor oversight by performing regular QC checks and ensuring inspection readiness at all times
• Member of the “Site Leadership Team”
• Member of the “Creative Lab”
Projektmanagement
1/2011 – 12/2011
Tätigkeitsbeschreibung
Operational team lead (Lead CRA) of an international CRA team
• Successful conduct of a license-relevant phase I study
• Spot award “gold” for extraordinary contribution to the company by regaining U.S market authorization for one product
• Contact person for project management
• Global Trial Master File Management
• Ensuring inspection readiness of the Trial Master File
• Coordination of study-related submissions to Ethics Committees (ECs) and competent authorities
• Implementation of study requirements within the team, performance and quality control
• Monitor and site assessment visits
• Co-monitoring and monitoring report review
• Mentoring of CRAs
• Training of CRAs and site personnel
Klinische Arbeiten
1/2008 – 1/2011
Tätigkeitsbeschreibung
As Clinical Site Manager responsible for monitoring and management of assigned investigative trial sites
• Blinded and unblinded monitoring of global, national, interventional and non-interventional clinical trials
• Contact person for investigators and study nurses
• Site selection, initiation, monitoring and close out
• Training of site personnel during international investigator meetings and site initiation visits
• Submission of study documents to ethics committees and competent authorities
• Close cooperation with other departments, e.g. Medical Affairs, CQA, Drug Safety, O&C, Regulatory, CTS, CTRRD
• Quality assurance and ensuring site compliance with all relevant laws, guidelines and regulations
• Site contract and budget negotiations
• Trial Master File maintenance
UCB Biosciences GmbH, Monheim
Department: Global Clinical Project Management
Clinical Trial Assistant
Klinische Arbeiten
6/2004 – 1/2008
TätigkeitsbeschreibungSupport of Project Management in all aspects of clinical trials
Eingesetzte QualifikationenKlinische Arbeiten
Zertifikate
Ausbildung
Düsseldorf
Düsseldorf
Münster
Über mich
Weitere Kenntnisse
Indications include Parkinson's disease, epilepsy, narcolepsy, restless legs syndrome, neuropathic pain, fibromyalgia, rheumatoid arthritis, osteoarthritis, systemic lupus erythematosus, malignant melanoma, skin cancer.
Persönliche Daten
- Deutsch (Muttersprache)
- Englisch (Fließend)
- Europäische Union
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