- Ensuring and coordinating a policy-compliant study, conducted in accordance with protocol, SOPs, local policies and legislation as well as ICH-GCP guidelines, quality and time management
- Appointed point-of-contact 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, and 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)
