Clinical Project Administrator I
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At Covance, you’ll redefine what’s possible and discover your extraordinary potential. You’ll have the opportunity to personally advance scientific research and make a difference in peoples’ lives with your bold ideas and unique point of view. We are looking for a Clinical Project Assistant (m/f) to be office based in Munich and working exclusively for one of our top clients, a global pharmaceutical company.
Sponsor Dedicated Clinical Project Administrator I (m/f) – full time, office based in Munich
Act as an internal point for the Clinical Project Team and coordinator of internal processes. Focus of the role in Munich will be ETMF Management but professional experience with EC submission is an advantage
+ Efficient and accurate administrative processing and preparation of forms concerning data collection, medication and other materials regarding medical projects
+ Set up, manage and keep up-to-date the medical project archives
+ Obtaining documents of potential sites and preparation of summaries for feasibility-studies to support the medical advisor
+ Preparation and submission of applications to the ethics committee
+ Management and archiving of SUSARs as well as shipment to investigators and ethical committees within the legally required timelines
+ Office organisation, meetings organisation, accounting of travel expenses, handling of invoices
+ files within given timelines in collaboration with the local teams according to SOPs and local regulations
+ Registration of new sites, submission of amendments and notification about start and end of a medical project to the ethics committee and local authorities
+ All phases of studies will be covered + Study Start Up activities
Education / Qualifications
+ Experience in pharmaceutical industry/R&D/Medical Affairs/Regulatory Affairs or Pharmacovigilance is appreciated
+ Good working knowledge of all relevant Standard Operating Procedures and guidelines in Good Clinical Practice
+ Interest to develop team spirit
+ Fluent in German and good English skills
Job Number 2019-31270
Job Category Administration/Clerical
Position Type Full-Time
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.