Agnes Gruber, PhD

Experience

• 

  Technical University Munich

  Oct 2002 - Jul 2003

  Master Diploma Student - DAAD scholarship

  Master thesis targeting the DNA sequence elucidation of the non-ribosomal peptide synthetase gene encoding the emetic toxin synthesis modules in Bacillus cereus

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  Helmholtz Centre for Infection Research

  Sept 2003 - Jul 2008

  PhD thesis targeting the role of the signaling molecule, autoinducer-2, in opportunistic pathogens Pioneered and set up a new screening assay in the laboratory to detect a signalling molecule

  • PhD student

    May 2004 - Jul 2008

  • Research Associate

    Sept 2003 - Apr 2004
• 

  Agricultural Biotechnology Center

  Apr 2009 - Dec 2010

  Postdoctoral Researcher

  Academic research targeting the role of the circadian rhythm (white-collar complex) and sexual reproduction in the fungus Fusarium verticillioides

• 

  Université de Genève

  Jan 2011 - Jul 2011

  Postdoctoral Researcher

  Academic research targeting the role of CCr4-Not complex in the yeast model

• 

  University Hospital Geneva

  Apr 2012 - Jul 2012

  Clinical research associate intern

  • Assisted in site monitoring of a phase III study in cardiology in the German-speaking part of Switzerland • Verified protocols and patient information sheets for their compliance with Swissethics guidelines• Assisted in developing an electronic CRF with secuTrial

• 

  IQVIA

  Jan 2014 - Aug 2017

  Project Management Analyst and Clinical Project Coordinator

  Project Management Analyst• Supported the project leads of observational/phase IV studies in generating and maintaining all the project management tools for scope, schedule, budget and quality management: monitor project progress by standard study metrics; generates and updates timelines in MS Project; proposes and updates risks, issues and lessons learned; controls and reviews the project budget for direct costs, investigator costs, and pass-through costs• Drafted and reviewed study plans, such as the project management plan, communication plan, and quality management plan• Supported project communications with internal and external teams and investigative sites: generates presentations for project review meetings; organizes and documents study team meetings, creates site communications and newsletters• Acted as a TMF oversightClinical Project Coordinator• Supported the project lead by administrative activities: organizes and documents study team meetings; maintains the TMF Core Files and the Project Management File; controls the TMF for completeness, consistency, and accuracy; controls and reviews the pass-through costs Show less

• 

  Genkyotex S.A

  Sept 2017 - Feb 2019

  Clinical Study Manager

  • Primary contact of a pivotal phase II study in liver disease for the CRO, central laboratory, CMC vendors, consultants, and patient organizations• Accountable for timelines and progress, and controls quality and budget• Monitored patient recruitment and site engagement, proposed and evaluated new sites, conducted motivational visits as well as by drafted and reviewed newsletters• Contributed to the revision of study documents such as protocol, ICF and investigator brochure• Reviewed and approved project plans such as monitoring plan, data quality plan, protocol deviation plan, automated edit check plan • Organized data monitoring committee review meetings and events for principal investigators Show less

• 

  Labcorp

  Feb 2019 - now

  • Key contact at the central laboratory for sponsors of phase I, II and III studies• Provides project oversight for a portfolio of projects by monitoring budget, risks and timelines• Leads and guides Covance assigned study teams to ensure a timely delivery and issue resolution to ensure a seamless delivery to clients• Motivates and facilitates efficient and successful interaction between the Covance internal teams and Covance assigned study teams• Thoroughly reviews the protocol, understands its specificities, and actively contributes to the design of the laboratory protocol• During the central laboratory design phase, highlights operational risks and bottlenecks and provides resolutions and workarounds Show less

  • Experienced Global Study Manager

    Oct 2022 - now

  • Global Study Manager

    Feb 2019 - Jun 2024