Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Lead clinical trials, manage risks, and ensure data integrity in a dynamic environment.
- Company: Join a leading pharmaceutical company focused on innovative clinical research.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Why this job: Make a real impact in clinical research while developing your analytical skills.
- Qualifications: 5+ years in clinical research with strong analytical and project management skills.
- Other info: Collaborative team culture with a focus on continuous improvement.
The predicted salary is between 36000 - 60000 £ per year.
The Manager, Clinical Risk & Analytics (CR&A) reports into the CR&A function and is responsible for cross-functional risk management and central monitoring activities for their assigned clinical trials in accordance with ICH GCP E6 requirements.
Summary Of Key Responsibilities
- Lead study teams in the identification and management of Critical to Quality (CtQs) factors, safety, and data integrity risks, operational and other protocol execution risks at study start and throughout the study.
- Lead the development of the Risk Management and Action Plan (Risk MAP), RBQM Plan, Integrated Data Quality Plan (IDQP), and Targeted SDV and SDR planning on assigned trials.
- Lead definition and selection of Key Risk Indicators (KRIs), and Quality Tolerance Limit (QTL) parameters and other applicable assessments and visualizations for their assigned trials.
- Lead delivery of timely and high-quality RBQM system analytic summaries reports and communicate findings to the cross-functional study team and CRO.
- Work with study team to define the risk mitigations and contingencies from centralized monitoring signals and findings.
- Perform QC and/or validation of study setup in RBQM system vs RBQM Plan and system specifications.
- Collaborate with assigned analyst and programmer to implement and refine study-specific KRIs and QTLs in the RBQM system.
- Ensure inspection readiness for risk management and centralized monitoring scope of activities on the assigned studies.
- Lead the study team through execution of Protocol Risk Assessment (PRA).
- Perform the execution and review of the centralized monitoring assessments and analysis, and diagnosing and explaining anomalies identified in the data and risks in the trial, as needed.
- Lead and coordinate with S&MH lead in the definition of site profile oversight tool(s) specifications in alignment with planned RBQM system analytics and outputs, as needed.
- Escalate serious risk or issues identified by the CR&A team assigned to the trial to the cross-functional study team, site and monitoring health (S&MH) team, and/or management and Quality, as needed.
- Coordinate and lead end of trial summarization of risk management activities, including QTL and other finding summaries, in preparation for inclusion to Clinical Study Report, as needed.
- Participate in continuous improvement and development activities in CR&A and may lead activities as required.
Requirements
- Proven experience in a clinical research environment.
- College degree, preferably in a scientific, analytical, or technical discipline.
- Minimum of 5 years’ experience in the pharmaceutical or CRO industry.
- Working knowledge of clinical development processes, understanding concepts and principles of study design, conduct and close out, as well as clinical program development.
- Knowledge of Good Clinical Practice/ICH E6 (R2+), ICH E8 R1 Guidelines and/or other applicable regulatory requirements.
- Experience and understanding of Risk Based Monitoring and Site Profiling Tools preferred.
- Familiarity and good understanding and knowledge of clinical trials risk management concepts and principles in the Pharma or CRO industry.
- Good understanding and knowledge of risk management concepts and principles.
- High degree of accuracy and attention to detail.
- Strong critical thinking and analytical skills, and aptitude for data analytics, mathematical and statistical concepts is a plus.
- Experience and good understanding of clinical trial data from various sources (e.g., Clinical devices, SDTM, RAVE, IRT, etc).
- Ability to work collaboratively in a team environment whilst managing changing priorities to achieve goals/targets.
- Project management capabilities.
- Excellent English oral and written communication skills.
Manager, Clinical Risk and Analytics in Maidenhead employer: Alnylam Pharmaceuticals
Contact Detail:
Alnylam Pharmaceuticals Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Manager, Clinical Risk and Analytics in Maidenhead
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical research field and let them know you're on the hunt for a Manager, Clinical Risk & Analytics role. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ICH GCP E6 requirements and risk management concepts. Be ready to discuss how you've tackled similar challenges in past roles. We want to see your critical thinking skills in action!
✨Tip Number 3
Showcase your analytical prowess! Bring examples of how you've used data analytics to improve clinical trial outcomes. This will demonstrate your ability to lead study teams effectively and manage risks, which is key for this role.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search. Let’s get you that dream job!
We think you need these skills to ace Manager, Clinical Risk and Analytics in Maidenhead
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the role of Manager, Clinical Risk & Analytics. Highlight your experience in clinical research and risk management, and don’t forget to mention any relevant projects or achievements that align with the job description.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for this role. Mention specific experiences that demonstrate your understanding of risk management and analytics in clinical trials, and how you can contribute to our team.
Showcase Your Skills: Don’t just list your skills; show us how you’ve used them in real-world situations. Whether it’s leading a study team or developing a Risk Management Plan, give us examples that illustrate your expertise and problem-solving abilities.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss out on any important updates from us!
How to prepare for a job interview at Alnylam Pharmaceuticals
✨Know Your Clinical Risk Management
Make sure you brush up on your knowledge of clinical risk management concepts and principles. Be ready to discuss how you've identified and managed risks in previous roles, especially in relation to Critical to Quality factors and data integrity.
✨Showcase Your Analytical Skills
Prepare to demonstrate your analytical skills by discussing specific examples where you've used data analytics to inform decision-making. Highlight any experience with Key Risk Indicators and Quality Tolerance Limits, as these are crucial for the role.
✨Familiarise Yourself with Regulatory Guidelines
Get comfortable with ICH GCP E6 requirements and other relevant regulatory guidelines. You might be asked about how these regulations impact your approach to risk management, so having a solid understanding will help you stand out.
✨Emphasise Team Collaboration
Since this role involves working closely with cross-functional teams, be prepared to share examples of how you've successfully collaborated in the past. Discuss how you manage changing priorities while still achieving project goals, as teamwork is key in this position.