A resourceful and results-orientated Clinical Research Director Worldwide, with over 35 year’s clinical research experience in a variety of studies worldwide. A leader who has successfully managed multi-disciplinary teams, providing a positive environment to complete essential clinical research driven tasks in the UK, Mainland Europe USA & Asia. A committed specialist, passionate about improving working practices, whilst ensuring patients have access to and receive, a high-quality service. Accomplished the creation of a Worldwide Blood collection process for analysis & reporting for a 66,000-patient orthopaedic implant recall programme. A versatile and adaptable Manager, able to effectively oversee a range of roles including, Clinical lead in the due diligence of 2 multi-million-pound corporate acquisitions within J&J  and DePuy Synthes. Pro-active and self-motivated, with valuable problem solving and decision-making skills and the ability to implement change, capturing requirements, developing solutions and delivering outcomes. Boasts a track record of multiple interactions with FDA, MHRA, BSi and other Notified Bodies, which have led to successful product launches. A calm and dedicated professional who is available to provide insight and expertise to your project.

Services offered & Experience.

• Clinical Research Strategy & Clinical Study Design
• Clinical Research Protocol Design & Development
• Case Report Form Design
• Clinical Study Management including liaison with Notified Bodies (e.g., BSi etc.) Competent Authorities (e.g., MHRA etc.) Ethics Committee Management including Submissions
• Preparation of Study Reports and Product Evaluations
• Support and Review of Clinical Publications    
• Surgeon Management & Liaison with Surgeon Teams
• Non-Exec Director Consultation and Guidance
• Guidance to Start-Up and SME Organisations
• In-house management of CROs

Therapeutic Areas

• Orthopaedics, knees, shoulder, hips, ankles, elbows & wrists
• Sports Medicine and Artificial joint tissues, cartilage, ligaments, and tendons
• Ophthalmology
• Would Care
• Vascular Access
• Cariology, CNS and Respiratory Drug Studies 

Career Achievements

• Successfully management of office based and/or remote based teams
• Directly responsible for setting up multiple study programme in the UK, EU and Asia Pacific
• Development and promotion of junior staff 
• Extensive knowledge of EU study processes and procedures
• Creating Departmental SOPs and policies
• Running extensive IIS Investigator Initiated Study Programmes
• Creating & managing a large, multination blood sampling process within a worldwide product recall
• Obtaining Multiple ODEP ratings in the UK for numerous orthopaedic implants