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Life Scientist as CRA (m/w)

Life Scientist as CRA (m/w)
Since 2003, VPM has been active in developing promising biopharmaceutical candidates from academic research to successful business concepts. Several products, ranging from small molecules, recombinant proteins up to gene-modified live vaccines and other ATMPs, have successfully been brought into clinical phases I and II. Subsequently, three out of five development candidates have been out-licensed by VPM. Based on this in-depth experience, the VPM team is a reliable partner for tailor-made consultancy and services along the complete pharmaceutical development chain. Currently, VPM is organizing multicentre clinical trials of Phases I, II and IIb in different Indications in Europe, South Africa and Asia.
In order to strengthen our clinical development team, we are looking for an experienced Clinical Research Associate (m/f). This permanent position is immediately available.
Job Profile:
·       Plan and facilitate clinical development of innovative medicines from bench to clinical proof-of-concept
·       Support regulatory submission (CTA, Amendments)
·       Review, collect and maintain essential documents
·       Provide input into feasibility, identify clinical investigators and conducts site evaluations
·       Ensures clinical study sites are conducting clinical trials in compliance with the respective protocol, SOPs and applicable ICH/GCP guidelines and regulations
·       Ensure appropriate safety reporting as well as tracking and reporting of adverse events
·       Identify site needs and site-related issues
·       Identify and report non-conformities and develop CAPA
·       Assist in preparing sites for audits, review audit reports and contributes to resolve findings
·       Build and maintain solid and long-term professional relationships with investigators and site staff
·       Ensure timely communication of information between Medical Department and site staff
·       Master degree in a relevant scientific discipline
·       Minimum five years work experience in clinical research and Phase I-III trials
·       Profound knowledge of clinical trial processes and operations
·       Familiar with ICH/GCP guidelines
·       Experience working as a CRA
·       Proficiency in English and German
·       Good working knowledge of common software packages
·       Willingness to frequent national and international business travel
·       Organizational skills including time management & prioritization
·       Attention to detail
·       Problem solver
·       Team worker
Contact details
Vakzine Projekt Management GmbH
Dr. med. Bernd Eisele, CEO
Mellendorfer Str. 9
30625 Hannover
+49 (511) 1699080


Art des Bewerbungszugangs
Kontakt für Bewerbungen
Vakzine Projekt Management GmbH
Dr. med. Bernd Eisele, CEO
Mellendorfer Str. 9
30625 Hannover
+49 (511) 1699080

Details der Stellenanzeige

Berufserfahrung vorausgesetzt
Deutschland (Niedersachsen)
30625 Hannover
Biologie & Life Sciences