Inka Schürmann

Responsible for the oversight of clinical sites and monitoring assigned clinical trials to ensure patient safety and quality study execution in accordance with prevailing laws, regulations, Good Clinical Practices and Pfizer standards. Close working relationships with the Alliance partner and Pfizer internal stakeholders. Acting as BU/Site interface and as the designated point of contact at a study level for other COLs, Medical and Alliance Partner globally; reviewing metrics.

As a Pfizer Global Health Fellow I worked together with a non-governmental-organization. I developed and implemented a quality assurance assessment leading at the Infectious Diseases Institute in Uganda to support the institutional objectives to be a Centre of Excellence in clinical research in sub Saharan Africa.

Planning, managing and coordinating clinical studies. Oversee Contract Research Organizations (i.e. CRO-Assessments and Co-Monitoring Visits). Implementation of monitoring oversight and oversight of the study sites focusing on quality improvements. Cross-project coordination; managing and coordinating several roles (COLs, CRAs, CTAs) on a cross-functional basis, including resource negotiations with upper management.

Planning, managing and coordinating clinical studies. Conducted program, protocol and site feasibilities; submissions to Ethics Committees, negotiating contracts, setting up the study budget. Awarded the role of Subject Matter Expert for „Clinical Trial Application“: Developing and updating an appropriate process memorandum describing the internal processes to implement applicable local laws and regulations governing clinical trial applications to local regulatory authorities.