Site and Monitoring Lead - FSP - Remote - UK

Parexel FSP has an upcoming exciting opportunity for an experienced Senior or Lead CRA to join one of our key sponsors in the UK as a Site and Monitoring Lead.

As the SML you will apply knowledge of regulations and GCPs as well as experience in monitoring to safeguard the quality of clinical trial execution at investigator sites and ensure the client’s oversight of CRO monitoring effectiveness.

This is a site-facing position that reports to the FSP Manager.

Some specifics about this advertised role

• Implements various types of oversight encounters and activities as applicable including
  • Site risk analysis
  • Site contacts
  • Monitoring visit report review
  • Sponsor Oversight Visits
  • System/data spot checks
• Creating study specific oversight plans
• Perform root cause analysis to identify issues and suggest actions to study Management and CRO partners.
• Build relationships with investigators and site staff
• Provide investigator sites less experienced in research
• Leading oversight and trend meetings

Who are Parexel

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.

We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.

You’ll be an influential member of the wider team.

What we are looking for in this role

For every role, we look for professionals who have the determination and courage always to put patient well-being first.

That to us is working with heart.

Here are a few requirements specific to this advertised role.

• Substantial Site Management or CRA Lead experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology. Specifically within oncology trials.
• Clinical or Advanced degree preferred, BSc or BA essential
• Excellent presentation skills.
• Client focused approach to work.
• Ability to interact professionally within a client organization.
• Flexible attitude with respect to work assignments and new learning.
• Ability to prioritize multiple tasks, and achieve project timelines; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise.