Recardio

Regenerative Cardiac Medicine of Tomorrow

  • Company
    • Profile
    • Management Board
    • Boards
    • Awards
  • Pipeline
    • Background
    • Rationale
    • Therapy
  • Clinical Studies
    • Phase 1
    • Phase 2B AMI
    • Phase 2B CHF
  • News & Events
    • Meet us at
  • Careers

Manager Clinical Operations Europe (m/f)

Reference number 2018-01

Your Responsibilities

  • Plan, implement and supervise clinical studies, working in close collaboration with project leaders, clinical research physicians and other stakeholders
  • Support of management and Boards with regard to the supervision of a clinical studies and assume responsibility for assigned task package (quarterly budgeting, CRO management, attending site initiation meetings etc.)
  • Participate in CRO management and surveillance of outsourced clinical studies
  • Assist in managing co-monitoring activities for assigned studies and participate in co-monitoring as needed
  • Oversee execution of one or more clinical studies, while ensuring that all trial deliverables are met according to specified timelines, budgets, resources etc.
  • Contribute to preparation of clinical program documents (investigator brochure, IND annual report, health authority briefing books and submissions)
  • Establish and manage study plan and ensure resolution of critical issues
  • Identify areas of best practice and process improvement
  • Develop study-related documents from concept sheets to final documents
  • Define, negotiate and ensure execution of study-related agreements, such as Clinical Study Agreements, CROs, Central Lab Services etc.
  • Presentation of corporate studies at internal and external meetings and conferences

Your Requirements

  • Academic degree in biological sciences
  • Minimum of three years’ professional experience in multinational clinical trial management, mainly in cardiovascular trials
  • Proven track record of compiling clinical study protocols, reports and publications
  • Demonstrable expertise relating to all aspects of the clinical development process
  • Ability to identify and resolve complex methodological issues relating to clinical studies
  • Well-developed organizational and interpersonal skills, complemented by attention to detail
  • Good knowledge of GCP and regulatory requirements (especially FDA and EMEA)
  • Finely honed written and verbal communication skills, underpinned by the ability to present clear
  • instructions/directions to teams within the organization
  • Willingness to travel (approx. 50%) with being located in Central Europe
  • Contact us
  • Imprint

© Recardio inc. 2018 · All Rights Reserved

Copyright © 2018 · Altitude Pro Theme on Genesis Framework · WordPress · Log in