At a Glance
- Tasks: Lead clinical risk management and ensure quality in global studies.
- Company: Join Orion, a leader in pharmaceutical innovation.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Collaborative team environment with a focus on innovation.
- Why this job: Make a real impact on patient safety and quality in clinical research.
- Qualifications: Experience in clinical risk management and strong analytical skills.
The predicted salary is between 63000 - 77000 £ per year.
Role Overview We are looking for a Clinical Risk Manager to play a key role in advancing Orion's global development portfolio through Risk Based Quality Management (RBQM).
In this strategic position, you will lead central monitoring activities, provide expert guidance on clinical risk management, and partner with cross‑functional teams to ensure the highest standards of quality, compliance, and patient safety across our clinical studies.
Your role In this role, you will: To manage and execute the Risk Based Quality Management processes and day‑to‑day activities related to Orion's propriety products development portfolio in conformance to all relevant law, regulations, guidelines, policies and procedures.
To be the subject matter expert for Central Monitoring RBQM systems.
Accountability for centralised monitoring activities across a number of global studies, analytical data review of key risk and presenting as an integral member of the Clinical Study Team.
The reviews include interpretation of Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs) available through an analytical tool as well as comprehensive review of supplemental operational data/trends and issues to be interpreted, reported, and presented to the study teams.
This role will lead, contribute, and drive continued process improvement and innovation activities, and industry collaboration in central monitoring capabilities.
Responsibilities Lead the cross-functional study team in the completion of RBQM-related study start‑up processes, such as protocol de-risking, Risk assessment and categorisation, and input into the monitoring strategy (SDV targets) whilst keeping RBQM concepts central to all study activities.
Responsible for development and authoring activities of the Clinical Trial Risk Management Plan.
Act as a subject matter expert for the configuration, implementation, and execution of RBQM system across studies.
Provide leadership, operational expertise, training, and guidance as a point of escalation for Central Monitoring issues related to RBQM system.
Conduct ability to build relationships internally and externally Confident and articulate communication skills (both written and verbal), with the ability to convey and present highly complex information to others clearly and logically Leadership skills including the ability to work within a multidisciplinary team environment and influence adoption of RBQM concepts High quality standards and attention to detail Aptitude for mathematical concepts, statistical concepts, and data analytics Your new team Orion's pharmaceutical innovations are created within its R
Clinical Risk Manager, Rbqm, R&D employer: Orion Pharma
Orion Pharma is an exceptional employer that fosters a collaborative and innovative work culture, particularly in the dynamic field of clinical data and AI. Employees benefit from a hybrid working model, competitive remuneration, and opportunities for professional growth, all while contributing to meaningful advancements in healthcare. With a focus on regulatory compliance and cutting-edge analytics, team members are empowered to make impactful decisions that drive clinical development forward.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Risk Manager, Rbqm, R&D
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We think you need these skills to ace Clinical Risk Manager, Rbqm, R&D
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Orion Pharma!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Orion Pharma that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Orion Pharma!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Orion Pharma, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Orion Pharma
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Orion Pharma that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Orion Pharma’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
