Risk Surveillance Lead - FSP - Remote

TN United Kingdom; Uxbridge; Remote; GBP 50,000 - 90,000; Full time

Job description

Risk Surveillance Lead - FSP - Remote, Uxbridge

Client:

Parexel

Location:

Uxbridge, United Kingdom

Job Category:

Customer Service

-

EU work permit required:

Yes

Job Reference:

77aa8ab483e7

Job Views:

3

Posted:

18.04.2025

Expiry Date:

02.06.2025

Job Description:

When our values align, there's no limit to what we can achieve.

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

What we are looking for in this 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