Project Management

  • Ensuring and coordinating a policy-compliant study conduct in accordance with protocol, SOPs, local policies and legislation as well as ICH-GCP guidelines, quality and time management
  • Contact person for the management team of the sponsor
  • Assistance in the selection and identification of suitable study sites
  • Organizing Investigator Meetings, Team Meetings and Study Workshops
  • Budget and contract negotiations with study sites and involved institutions, resident doctors, vendors, etc.
  • Obtaining necessary insurance cover including budgetary negotiations with insurance agencies
  • Preparation and implementation of study-specific training
  • Preparation of all study documents, such as protocol synopsis, monitoring plan, patient informed consent
  • Qualitative verification of monitoring reports
  • Creation and monitoring of patient recruitment strategies and patient enrolment plans
  • Conducting co-visits at participating study sites for quality control and assurance
  • Assistance in the preparation and execution of sponsor audits and inspections, including preparation of audit and inspection reports (CAPAs)