Risk Surveillance Lead - FSP - Remote

Parexel are currently recruiting for an experienced Risk Based Quality Management professional to join one of our key sponsor programs in the EMEA region.

This is a 100% home based role and we are open to candidates in any of the following countries: France, Ireland, Italy, Poland, Romania, Serbia, Spain, Norway and the UK.

In this role, you will be responsible for driving the adoption of RBQM practice at trial level and oversee the implementation, and continuous improvement. Working in a matrix environment you’ll have overall accountability for the surveillance of quality risks associated with your assigned trials.

Some specifics about this advertised role

• Facilitate trial protocol risk assessment across multiple domains (clinical, operational, data management, vendors, regulatory etc.) associated to critical-to-quality (CtQ) data and processes.
• Facilitate risk review meetings and discussions with study / program team members to effectively communicate and discuss the findings, support, and encourage robust root cause identification and mitigation strategies.
• Responsible for drafting, maintaining, and archiving the study specific documentation of risk management activities e.g., Integrated Quality Risk Management Plan (IQRMP)
• Acts as a change agent, champion, subject matter expert and point of contact of RBQM methodology, leading study teams to understand and follow the best practices to achieve maximum benefit

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 the 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.

• Minimum of 6 years of experience in the pharmaceutical or CRO industry
• Minimum of 2 years of experience in Risk Based Quality Management
• Robust understanding of the drug development process and clinical trial execution
• Knowledge of industry regulatory standards
• M.S/M.A/Ph.D or B.A/B.S/nursing degree is essential
• Experience in risk management, sponsor audits and health authority inspections, root cause analyses and mitigation strategies as well as Corrective Actions Preventive Actions

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