freiberufler Lead CRA / Study Manager Freelance auf freelance.de

Lead CRA / Study Manager Freelance

offline
  • auf Anfrage
  • 10115 Berlin
  • Europa
  • en  |  de  |  he
  • 24.08.2020

Kurzvorstellung

Over 16 years of experience as a free-lance contract Trial Manager and LCRA working on national and multinational phase I -III drug and device trials for large pharma and bio-techs.

Qualifikationen

  • Drug Discovery13 J.
  • Klinische Arbeiten13 J.
  • Klinische Forschung13 J.
  • Medizinforschung13 J.
  • Neurologie
  • Onkologie

Projekt‐ & Berufserfahrung

Lead CRA
Kundenname anonymisiert, Berlin
10/2004 – 9/2017 (13 Jahre)
Life Sciences
Tätigkeitszeitraum

10/2004 – 9/2017

Tätigkeitsbeschreibung

• Vendor Management
• Registration of the trial in EudraCT
• Managing site contracts and investigator payments
• Organizing of kick-off meetings and investigator meetings
• Conduct of kick-off meetings and investigator meetings
• Planning, conduct and FU of regular TCs with sponsor
• Conduct of regular safety TCs with medical monitor(s) and investigators
• Preparation and conduct of data management data/query reconciliation meetings
• Creation of weekly tracking reports and monthly reports for sponsor
• Site feasibility analysis, site selection and all types of site montoring visits (SIV to COV)
• Application for subject trial insurance
• Control of periodic safety reports to authorities
• Control of documentation for ethics committee submissions including amendments
• Review of protocols and PICs and other essential documents
• Performing site feasibility assessments with LCRA
• Control of documentation for regulatory authority submissions including amendments
• Control of CTAF, Substantial Amendment Notification Form
• Control of regular safety updates and reports to EC
• Tracking trial supplies i.e lab kits, leased equipment etc.
• Preparing for EC audits and inspections by regulatory authorities
• Working with clinical trial management systems (IMPACT)
• Working with Medidata Rave, IBM Clinical Development
• Authoring SOPs

Eingesetzte Qualifikationen

Medizinforschung, Forschung & Entwicklung, Drug Discovery, Klinische Forschung, Klinische Arbeiten

Zertifikate

Parexel Akademie Clinical Data Manager / Clinical Research Associate
2004

Ausbildung

Economics / German
Bachelors
1987
University of Michigan Ann Arbor Michigan

Über mich

Over 16 years of experience as a contract CRA, Lead CRA and Study Manager. Phase I-IV trials. Drugs and Devices.

Indications:
• Endocrinology: DM2
• Neurological: Parkinson's Disease, Fibromyalgia
• Cardiovascular: preserved EF and reduced EF
• Oncology: colorectal, breast (advanced and metastasising), SCLC, pancreatic, hepatic
• CNS: RRMS, SPMS
• Respiratory: COPD, PAH
• ATMP: Mesenchymal Stromal Cells in Critical Limb Ischemia, Intermittent Claudication
• Neurology: Treatment resistant depression

Weitere Kenntnisse

Parexel Akademie Clinical Research Associate Jan - Oct 2004

Persönliche Daten

Sprache
  • Deutsch (Fließend)
  • Englisch (Muttersprache)
  • Hebräisch (Gut)
Reisebereitschaft
Europa
Arbeitserlaubnis
  • Europäische Union
  • Vereinigte Staaten von Amerika
Home-Office
bevorzugt
Profilaufrufe
1482
Alter
59
Berufserfahrung
20 Jahre und 2 Monate (seit 09/2004)
Projektleitung
5 Jahre

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