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Karine LUGARDON

Illkirch Graffenstaden Cedex

En résumé

Pas de description

Entreprises

  • Transgene - Program Leader

    Illkirch Graffenstaden Cedex 2017 - maintenant
  • DOMAIN THERAPEUTICS - Senior Scientist - Project Manager

    2012 - 2017
  • ROCHE - Clinical Pharmacology Unit - Deputy Site Head / Business Division Lead

    2009 - 2011 - Ensuring the daily smooth running of the Unit as member of the leadership team
    - Implementation of the development’s strategy through the extension of capabilities and a better alignment to the Disease Therapeutic Area’s strategies
    - Responsibility for feasibility, scheduling and budgeting of clinical trials and related resource planning and contracting
    - Management of study management and subject recruitment teams
    - Interaction with internal/external partners, Ethics Committee and Health Authorities
  • ROCHE - Clinical Pharmacology Unit - Head of Strategic Support

    2008 - 2009 - Ensuring the daily smooth running of the Unit as member of the leadership team
    - Management of non-medical staff and activities to optimize an environment enabling the conduct of clinical trials: human resources (staff recruitment, development, coaching and performance management), study management, research laboratory, subject recruitment, finance (budget and projection), admin assistant and building capability (staff, facilities, equipment)
  • ROCHE - Clinical Pharmacology Unit - Site Head ad interim

    2008 - 2008 - Leading all the activities in the Unit and interacting with internal/external stakeholders
  • ROCHE - Clinical Pharmacology Unit - Business Manager

    2006 - 2007 - Ensuring the interface with internal/external partners to guarantee a centralised and optimal communication for all the study steps along with study management team
    - Management of contracts, cost estimates, selection of external vendors and experts
    - Identification and implementation of new collaborations (expertise, techniques, analyses) according to study needs
    - Promotion of Unit’s activities to internal/external partners
  • FORENAP PHARMA - Business Development Manager

    2003 - 2006 - Development and management of international customers’ network and promotion of company’s services
    - Set up and negotiation of cost estimates, contractual conditions and their follow up
    - Coordination of full protocol feasibility including design, Ethic Committee considerations, assessments, timelines and recruitment
  • FORENAP PHARMA - Clinical Project Manager

    2000 - 2003 - Conception and preparation of protocols, inform consent forms, regulatory documents for submission to Ethics Committee and writing of clinical study reports.
    - Review/update of study documents (CRF, Trial Master File, study specific guidelines…)
    - Coordination and management of internal/external services partners to ensure timely and cost effective progression of studies.
    - Ensuring the respect of internal SOPs and ICH-GCP guidelines
    - Management of the relationships with sponsors for study conduct related activities

Formations

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