Manager, Study Start Up

The Study Start-Up Manager is accountable for study planning, SSU activities and activation deliverables of assigned projects in compliance with clients processes, GCP/ICH and regulatory requirements in a standalone country, OPC (operating country) or satellite country. Leads all SSU activities of assigned projects in close collaboration with SSO Feasibility Manager and SSO Site Partnership Manager as well as the global study team. In satellite countries acts as primary back-up and deputy of the country manager. Supports country SSU strategy in close collaboration with SSO Study Start-Up Team Lead, SSO Country Head Portfolio / SSO Cluster Head Portfolio. Collaborates with SSO Country / Cluster Head Portfolio, SSO Portfolio Team Leads and global study team to ensure SSU timelines and deliverables are met according to country commitments. Accountable for timely start-up activities from country allocation until Green Light (ready to initiate site millstone) in assigned projects. Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements. Implements innovative and efficient processes which are in line with clients strategy. Supports study feasibility in close collaboration with Feasibility Manager and Site Partnership Manager as well as the global study team.