Risk Surveillance Lead - FSP - Remote
United Kingdom, Remote Additional Locations France-Paris-Remote; Ireland-Remote; Italy-Remote; Norway-Remote; Poland-Remote; Romania-Remote; Serbia-Remote; Spain-Remote Job ID R0000032752 Category Project Leadership Date Posted 04/16/2025Overview
As a part of the global Project Leadership group at Parexel, you are responsible for leading cross-functional teams to deliver high-quality and patient-focused clinical trials and help bring life-changing treatments to market faster. You collaborate with clients and internal stakeholders to identify project requirements, develop project plans, and manage project timelines and budgets. The role requires strong leadership and communication skills, the ability to work under pressure, and a passion for improving patients' lives.
In return, Parexel offers a supportive work environment, and a high degree of empowerment and accountability to lead your studies. Within this role, you work with a diverse set of clients and therapeutic areas, and you are encouraged to take on new challenges and pursue your interests.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Adaptable
- Communicator
- Collaborative
- Leadership
- Proactive
- Problem-solver
About This Role
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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Potential Career Path
Parexel offers a growth path with diverse therapeutic areas and clients, so you can grow according to your interests.
- Associate Project Leader
- Project Leader
- Senior Project Leader
- Associate Project Director
- Project Director
- Director, Project Leadership
- Senior Director, Project Leadership
Employee Insights
Why Project Leaders work at Parexel
