As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Are you a local Study Manager who is looking for the next challenge? If so then this may be the role for you!
We are continuing to expand our CTM Team within a client dedicated FSP role. This role requires you to Lead and Manage trials and teams across a cluster, so you will be working with teams in the UK, ROI, Belgium and The Netherlands. You will be involved in Oncology studies, or CAR-T trials, and/or Haematology, Immunology and Cardiovascular diseases.
Other Key duties include:
• Reviewing Protocols and Consent forms
• Organising Kick off meetings
• Training CRA teams
• Organising INV meetings
• Monitoring and tracking start up activities
• Co-ordinating the submission process and ethics approvals
• Supporting monitoring teams – the CRAs will approach the CTM for advice when needed
• Oversee the monitoring activities e.g. review trip reports, check compliance, co-monitoring
• Developing the strategy, tools and training to oversee and assess the performance of CRA’s – trip report review, monitoring tool compliance, AFV
• Identifying risks, follow up on issues, timely response to audit inspection reports
This particular role is a client dedicated one where you will work exclusively on one sponsor’s trials and SOPs; a client that values their staff and puts an emphasis on career development.
Reasons to apply:
• This client’s team is cohesive and stable with low attrition rates
• The Uxbridge office is impressive; modern and well equipped with a great canteen & free parking available
• Free shuttle bus to and from Uxbridge station to the client offices
• Free on-site gym
• Work from home 2-3 days per week
Requirements:
• A minimum of 5 years experience within Clinical Research
• Experience of Clinical Trial design
• The ability to plan, set and manage Clinical Trial budgets.
• Previous CRA experience in the UK is preferable
Other Information: This role is a full time & permanent position to be employed through Fortrea. Candidates will need to be office based in Uxbridge 50% of their time (ie.2-3 days per week) with the remaining time home working.