Clinical Site Manager
As a proven and successful clinical trials specialist, you’ll be our first Clinical Site Manager in Europe. You’ll play a critical role in our success; conducting everything from study site selection to monitoring; and from write up to helping select and manage our CROs. Together our success has the potential to benefit millions of lives worldwide.
You’ll need to be highly experienced in the principles of GCP and managing multiple study sites, as well as supporting principle investigators. We also like to think a bit differently and to keep things straightforward, whilst of course also being fully compliant. So there’s a huge opportunity here to help shape and influence our approach to clinical trials for years to come. You’re going to need to be self-starter, as we’re building a new team here and challenging the traditional approaches.
Reporting to our Senior Director, Head of Clinical Operations based in the USA, you’ll take responsibility across Europe for:
• Writing study site visit reports and reviewing reports written by CRO monitors, ensuring compliance with study plans, SOPs and ICH GCP
• Ensuring proper maintenance of study files, including investigator site files according to ICH GCP
• Acting as the primary Sponsor point of contact for site staff, other than patient safety issues
• Ensuring support of the site during start-up activities such as budget and contract negotiations, developing informed consent forms, IRB/EC submissions and the collection of essential documents
• Developing and participating in the review of clinical trial documents including protocol training documents, site selection/information forms, site reference manuals, pharmacy manuals, monitoring plans and informed consent documents
• In collaboration with CPM, manage oversight of CROs, field monitors, selecting study vendors and clinical trial sites
• Reviewing monitoring trip reports and track resolution, including the escalation of all issues
• Co-monitor at investigative sites to evaluate study site and field monitor performance
Ideally, you’ll be located within easy striking distance of Oxford as we’d very much like you to feel part of our team. As you’ll be travelling quite a bit that isn’t essential though. We’re pretty sure you’ll feel part of the team very quickly anyway.
If you’ve had an exceptional track record in clinical trials, want to be in at the “beginning” of building our approach to site management and want to have the opportunity to shape a new approach this could be the ideal role. We’d be delighted to hear from you.