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Study Coordinator (m/f/d) (full time)

BioAgilytix Europe GmbH, Lademannbogen 10, Hamburg, Hamburg, Germany Req #115
Friday, November 12, 2021
BioAgilytix is a leading contract research organization (CRO) that specializes in large molecule bioanalysis. Our fully integrated laboratory services support every stage of biologics development, from early discovery through pre-clinical studies and clinical phases, in a fully regulated environment. The best science demands the best people, and our global team of professionals in Hamburg, Germany; Durham, North Carolina; Boston, Massachusetts; San Diego, California; and Brisbane and Melbourne Australia bring a passion for helping pharma and biotech companies achieve more for the patients they serve. Outstanding science requires great people. At BioAgilytix, you will be part of a highly professional team that supports cutting-edge bioanalytical methods with world-class biopharmaceutical services.

Your role/tasks:

Study Coordination

  • Overall support of Principle Investigators for study management, study progress monitoring and study documentation
  • Actively collaborate with Analytical Project Manager, Operations, Quality Control, Quality Assurance and Finance to facilitate a successful study progress and project documentation
  • Provide sample coordination and administration including sample reconciliation
  • Assist in generation of reports, including compiling report material, preparing report table and data management
  • Ordering and tracking status of material and reagents including the inventory and expiry date
  • Assist in tracking and resolution of deviations and internal audit observations
  • Updating project tracking tools, e.g. Master Schedule
  • Assist in archiving of study binders
  • Support in data controlling (QC), peer review of experimental results and data cross check for data submission to clients

 

Client Communications/Coordination

  • Coordination of client communications and meetings including meeting agenda and minutes and action item tracking
  • Coordination of external partners, e.g. for sample shipments or reagent supply

 

Data Management

  • Data management using Watson LIMS or equivalent systems
  • Support report generation including processing, reviewing and creating data tables

   

Position Requirements:

  • Education in biotechnology or natural science or equivalent
  • Experience in GxP (GLP, GCP, GMP, GDP) regulations preferred
  • Industry or CRO experiences preferred
  • Good knowledge of MS Office
  • Fluent skills in English and German (most documents are in English, TC with client is also in English)
  • Excellent Planning and Organizing skill
  • Strong communication skills
  • Team worker
  • Goal-oriented working method

 

What we offer you: Unlimited employment relationship Flexible working hours Collegial work in a highly motivated team Structured induction (onboarding, mentoring and briefing) Subsidy for the public transport network / profit ticket and company parking spaces Participation in company pension scheme and/or capital-forming benefits Additional company health insurance Team events Corporate benefits Employee referral program Good working atmosphere in an international environment Free drinks and fruit

Other details

  • Pay Type Salary
Location on Google Maps
  • BioAgilytix Europe GmbH, Lademannbogen 10, Hamburg, Hamburg, Germany