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- Tasks: Oversee risk management for clinical projects and develop risk assessments.
- Company: Join a leading organisation in clinical research with a focus on innovation.
- Benefits: Flexible home-based work, competitive salary, and opportunities for professional growth.
- Other info: Be part of a dynamic team with a commitment to continuous improvement.
- Why this job: Make a real impact in clinical trials while enhancing your risk management skills.
- Qualifications: Degree and 4-6 years of relevant experience in clinical trials required.
The predicted salary is between 46000 - 52000 ÂŁ per year.
Responsible for the oversight of risk management activities on a portfolio of clinical projects in accordance with ICH GCP E6 requirements. The Clinical Risk Lead will coordinate the development of project specific risk assessments, risk management plans and Integrated Strategic Monitoring Plans (ISMPs) during study start‑up whilst driving compliance to these plans throughout the project lifecycle. The Clinical Risk Lead will maintain the risk library and provide guidance to ensure consistency within the organization in terms of risk assessment and management. The Clinical Risk Lead will assist in the development of the clinical monitoring strategy, and the application of RBQM principles to other functional plans in collaboration with other functional leads and, where required, will develop and deliver training to the study team regarding the risk assessment and the clinical monitoring strategy.
Risk Management Activities
- Coordinate and conduct an initial risk assessment during the request for proposal and bid‑defense stages with the key stakeholders from each department.
- Lead the cross‑functional project team in identifying critical variables and key study‑specific risks using the risk assessment tool and key risk indicators library post study award.
- Assist with the creation and maintenance of the project specific Risk Management Plan.
- In conjunction with Data Management and the project team coordinate the project specific QTL build at study start and reviews throughout the project.
- Work with the study team to develop the study’s Project Plans & ISMP, including but not limited to Monitoring Plans (On‑site, Central, Remote), under the direction of the Project Manager.
- Communicate and coordinate risk identification and management activities with the cross‑functional team on study‑specific risks identified at specified timepoints.
- Develop and recommend risk mitigation strategies by working with cross‑functional teams to document and elevate issues identified, develop and track strategies to mitigate them, and conduct root cause analysis to institute corrective and preventative action plan.
- Conduct periodic reviews of Risk Management Plans as well as previously and newly identified risks.
- Update Risk Management Plan and any other Project Plans based on updated risk assessment.
- Coordinate project specific user access reviews of the Risk Management system.
Study Documents and Plans
- Develop and deliver training to the study team regarding the risk assessment, centralized monitoring and the wider risk‑based monitoring strategy.
- Development and maintenance of Risk Library.
- Development of Project Plans to manage identified risks.
- Draft initial Risk Assessment with risk planning tool and support from cross‑functional team.
Subject Matter Expert
- Provide coaching for cross‑functional team as needed regarding functional delivery, evaluation of project risks and plans to mitigate risks identified.
- Provide expertise for the development and maintenance of the monitoring strategy required for the trial based on identified risks.
- Review study protocols to highlight any areas of risk.
- Provide input related to clinical monitoring services on proposal for business development.
- Present to internal/external clients on Risk Management and oversight.
- Become SME on the Risk Management System(s) used within the organization and deliver training on the system(s) as required.
- Participate and contribute to process improvement initiatives and business projects.
Other Responsibilities
- Participate in the development and ongoing review of the risk management process.
- Stay informed on current interpretations and application of regulatory expectations in terms of risk management.
Qualifications
- Minimum of an undergraduate degree and 4‑6 years of relevant experience (including a minimum of 3 years in clinical trials), with knowledge and prior experience of Risk Based Quality Management concepts.
- Proficiency with MS Office, strong written and verbal communication skills, and highly effective interpersonal and organizational skills.
- Demonstrated attributes: proactive, detail‑oriented, critical thinker, task‑driven and highly organized.
- Ability to apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical trial, and ability to work in a global environment and cross‑functional team.
Working Conditions
- Home‑based.
*Accommodations for job applicants with disabilities are available upon request.
Clinical Risk Lead employer: Alimentiv
Contact Detail:
Alimentiv Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Risk Lead
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical trials field and let them know you're on the lookout for opportunities. You never know who might have the inside scoop on a Clinical Risk Lead position 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 strategies. Be ready to discuss how you've applied these principles in past roles, as this will show you're the right fit for the job.
✨Tip Number 3
Don’t just wait for job postings to come to you! Keep an eye on our website and apply directly through it. This way, you’ll be one step ahead and show your enthusiasm for the role.
✨Tip Number 4
Follow up after interviews with a thank-you email. Mention something specific from your conversation to remind them of your fit for the Clinical Risk Lead role. It’s a small gesture that can make a big difference!
We think you need these skills to ace Clinical Risk Lead
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Clinical Risk Lead role. Highlight your experience with risk management in clinical projects and any relevant training you've delivered. We want to see how your skills align with our needs!
Showcase Your Experience: When detailing your work history, focus on your previous roles in clinical trials and risk management. Use specific examples that demonstrate your ability to identify and mitigate risks, as well as your experience with ICH GCP E6 requirements. This will help us see your fit for the position.
Be Clear and Concise: Keep your application straightforward and to the point. Use clear language and avoid jargon unless it's relevant to the role. We appreciate a well-structured application that makes it easy for us to understand your qualifications and experiences.
Apply Through Our Website: Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensures you’re considered for the Clinical Risk Lead position. Plus, it helps us keep everything organised!
How to prepare for a job interview at Alimentiv
✨Know Your Risk Management Inside Out
Make sure you’re well-versed in risk management principles, especially those related to clinical trials. Brush up on ICH GCP E6 requirements and be ready to discuss how you've applied these in past projects.
✨Prepare for Scenario-Based Questions
Expect questions that ask you to demonstrate your problem-solving skills in real-world situations. Think of specific examples where you identified risks and implemented mitigation strategies, and be ready to share them.
✨Familiarise Yourself with the Company’s Projects
Research the company’s portfolio of clinical projects and understand their approach to risk management. This will help you tailor your responses and show that you’re genuinely interested in their work.
✨Showcase Your Communication Skills
As a Clinical Risk Lead, you'll need to communicate effectively with cross-functional teams. Be prepared to discuss how you’ve successfully collaborated with others and delivered training or presentations in the past.