Clinical Trial fluent German  

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  • Date Listed11/10/2019
  • Location
  • Advertised ByAgency
  • Job TypeFull-Time

Clinical Trial Associate fluent German

Responsibilities

  • Initiate investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents, serve as the point of contact for a site’s ERB and Competent Authority (CA)(where applicable), communicate and negotiate budgets with site personnel and internal teams, negotiate and obtain fully-executed contract, track and ensure site compliance to required training, and effectively drive timelines aligned with company priorities
  • Communicate directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out
  • Identify, communicate, and resolve issues
  • Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems
  • Leverage previous site / review board engagements to efficiently drive new work
  • Populate internal systems to ensure accuracy of trial / site performance
  • Understand and comply with procurement, legal and financial requirements and procedures
  • Populate Trial Master Files and libraries for future reference
  • Provide feedback and shared learning for continuous improvement
  • Leverage trial prioritization
  • Anticipate and monitor dynamically changing priorities

Basic Qualifications

  • Bachelor’s degree preferably in a scientific or health related field, two years clinical research experience or relevant experience preferred
  • Understanding of the overall clinical development paradigm and the importance of efficient site initiation
  • Applied knowledge of project management processes and skills
  • Appreciation of / experience in compliance-driven environment
  • Ability to learn and comply with financial and legal guidelines and policies (budget and contract)

Additional Skills/Preferences

  • Effective communication, negotiation, and problem solving skills
  • Self-management and organizational skills
  • Fluent in English and German

Salary: 35-50K+5% bonus

Permanent

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