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- Tasks: Lead risk management for clinical projects and ensure compliance with industry standards.
- Company: Dynamic healthcare organisation focused on innovative clinical solutions.
- Benefits: Flexible home-based work, competitive salary, and opportunities for professional growth.
- Why this job: Make a real difference in clinical trials while developing your expertise in risk management.
- Qualifications: Undergraduate degree and 4-6 years of relevant experience in clinical trials.
- Other info: Join a collaborative team and contribute to process improvement initiatives.
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 startâup 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 bidâdefense stages with the key stakeholders from each department.
- Lead the crossâfunctional project team in identifying critical variables and key studyâspecific 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 (Onâsite, Central, Remote), under the direction of the Project Manager.
- Communicate and coordinate risk identification and management activities with the crossâfunctional team on studyâspecific risks identified at specified timepoints.
- Develop and recommend risk mitigation strategies by working with crossâfunctional 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 riskâbased 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 crossâfunctional team.
Subject Matter Expert
- Provide coaching for crossâfunctional 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 4â6 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, detailâoriented, critical thinker, taskâdriven 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 crossâfunctional team.
Working Conditions
- Homeâbased.
- Accommodations for job applicants with disabilities are available upon request.
Clinical Risk Lead in Cambridge employer: Alimentiv
Contact Detail:
Alimentiv Recruiting Team
StudySmarter Expert Advice đ¤Ť
We think this is how you could land Clinical Risk Lead in Cambridge
â¨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 hunt for a Clinical Risk Lead role. You never know who might have the inside scoop on job openings or can put in a good word for you.
â¨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.
â¨Tip Number 3
Donât just apply anywhere; focus on companies that align with your values and career goals. Use our website to find roles that excite you and tailor your approach to each one, highlighting your relevant experience in risk management.
â¨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. Mention something specific from your conversation to remind them why youâre the perfect candidate for the Clinical Risk Lead position.
We think you need these skills to ace Clinical Risk Lead in Cambridge
Some tips for your application đŤĄ
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 trials and any relevant skills that match the job description. We want to see how you fit into our team!
Showcase Your Experience: When detailing your past roles, focus on specific projects where youâve led risk assessments or developed risk management plans. Use examples that demonstrate your proactive approach and critical thinking skills, as these are key attributes we value.
Be Clear and Concise: Keep your application straightforward and to the point. Use clear language and avoid jargon unless itâs relevant to the role. We appreciate well-structured applications that make it easy for us to see your qualifications at a glance.
Apply Through Our Website: Donât forget to submit your application through our website! Itâs the best way for us to receive your details and ensures youâre considered for the role. Plus, it shows youâre keen to join the StudySmarter team!
How to prepare for a job interview at Alimentiv
â¨Know Your Risk Management Inside Out
Make sure you brush up on your knowledge of risk management principles, especially those related to clinical trials. Be ready to discuss how you've applied RBQM concepts in your previous roles and how you can bring that expertise to the table.
â¨Prepare for Scenario-Based Questions
Expect questions that ask you to demonstrate your problem-solving skills in real-world scenarios. Think of specific examples where you've identified risks and implemented mitigation strategies, and be prepared to walk the interviewer through your thought process.
â¨Familiarise Yourself with the Companyâs Projects
Research the companyâs portfolio of clinical projects and understand their approach to risk management. This will not only help you tailor your answers but also show your genuine interest in the role and the organisation.
â¨Showcase Your Communication Skills
As a Clinical Risk Lead, you'll need to communicate effectively with cross-functional teams. Prepare to discuss how you've successfully collaborated with different departments in the past and how you plan to facilitate communication in this role.