Michael Stephens

Background

About Michael Stephens

More than 25 years dynamic management experience of effectively leading clinical research operations projects, teams & people in UK, US, EU, & Australia- Successful experience of formal meetings with Regulatory Agencies (EMA, FDA, MHRA, PEI, AEMPs and others)- I have delivered both strategic & tactical operational roles within Remote home office, Corporate, Regional or Affiliate settings, including WFH in a full home office set-up for the past 9 years- Achieved positive results in clinical research through effective vendor management, to meet recruitment targets, reporting timelines, and budget limitations whilst maintaining a state of Inspection Readiness- Leadership of Clinical Field Operations teams in the execution of clinical trials using in-house, out-sourced, and hybrid clinical teams, including use of an FSP for US site management and monitoring, and the use of SMOs- I have driven significant change management process initiatives to enhance departmental effectiveness, efficiency & quality- Experience of working in collaboration with Regulatory Affairs colleagues with both the EMA & FDA on the clinical component of BLA/MAA/NDA filings. Goal: To be the best that I can be. Specialties: Clinical Research deliverables to time, quality & budget. Team building & performance management. Organization building and change management. Resource allocation, clinical trial budget forecasting and management. Regulatory inspection readiness and Agency GCP Inspections. CRO/Sponsor relationship management. Clinical site relationship management. Vendor management of IVRS, central laboratories & EDC. On a personal note, my main interests reflect my team player mentality in that they are mainly of a sporting nature. Football, rugby union, cricket and gym training are my favourites, whenever time permits. I am a season ticket holder at my beloved Old Trafford. I also enjoy travel, films, and cooking.