At a Glance
- Tasks: Join our team to manage clinical risks and support groundbreaking medical innovations.
- Company: Premier Research, a leader in transforming biotech and pharma ideas into reality.
- Benefits: Flexible work-life balance, professional growth opportunities, and a supportive team environment.
- Other info: Collaborate with global teams and enjoy a dynamic work culture.
- Why this job: Make a real difference in patients' lives while developing your career in health sciences.
- Qualifications: Bachelor's in Biological or Health Sciences and 8+ years of clinical research experience.
The predicted salary is between 56700 - 69300 £ per year.
Premier Research is looking for a Clinical Risk Manager I to join our Clinical Management team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognise our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
- Support Clinical Bidder, Proposals and Business Development by providing the rationale for the overarching monitoring strategy based on initial risk assessment, as needed.
- Upon study award, complete the study RACT for complex and/or global trials, which includes identification of Critical Data and Critical Processes, as well as protocol execution risks and cross-functional mitigative strategies for the identified risks, with study team input.
- Evaluate whether Quality Tolerance Limits (QTLs) should be considered, and if so, lead discussion with required functions to establish initial QTL parameters.
- Confirm the proposed custom monitoring strategy is fit for purpose and risk proportionate.
- Ensure the Central Monitor, if in scope, has the required tools to perform aggregated data reviews via analytics, or other methods.
- Create configuration notes for programmers of Clinical Analytics.
- Author the Integrated Quality Risk Management Plan (IQRMP) for assigned studies.
- Serve as a Subject Matter Expert (SME) on Risk Management and Risk Based Monitoring (RBM) activities for assigned studies.
- Support functional leads in completing functional project plans, ensuring relevant mitigations are captured as expected.
- Support ongoing cross-functional protocol execution risk reviews through the entire project life cycle.
- Ensure inspection readiness related to Risk Management and RBM strategy by maintaining accurate and complete documentation.
Qualifications:
- Bachelors in Biological Sciences, Health Sciences and/or related disciplines in the health care domain.
- Significant clinical research experience, 8+ years of related experience to RBQM, Central Monitoring and Project Management.
- Subject matter expertise on RBQM, KRI, QTLs, QbD, Centralized Monitoring, Budgeting and Contracts.
- Excellent analytical, computational, judgement and decision-making ability.
- Strong fundamental understanding of statistical concepts, statistical analysis techniques and Integrated Quality Risk Management (IQRM) theories.
- Lead process improvement initiatives at department/organizational level.
- Expertise with MS Excel, Business Intelligence tools and leverage data visualisations for decision making.
- Experience of collaborating with cross-functional global teams for solving complex problems.
- Excellent verbal and written communication skills in English.
- Ability to travel up to 20% for sponsor meetings.
Location: United Kingdom
Type: Full time
Risk Manager - Health employer: Premier Research
At Premier Research, we pride ourselves on being an exceptional employer that values the contributions of our team members in the vital field of clinical research. Our supportive work culture fosters professional growth and offers flexible working arrangements, ensuring a healthy work-life balance while you play a crucial role in delivering innovative medical solutions. With opportunities for continuous development and collaboration within a global team, you'll find meaningful and rewarding employment that truly makes a difference in patients' lives.
StudySmarter Expert Advice🤫
We think this is how you could land Risk Manager - Health
✨Get Involved with Local Health Initiatives
Join local community health events or volunteer for organisations like public health agencies. This not only builds your experience but also helps you network with industry professionals who might know of openings at places like Premier Research.
✨Tap into Professional Associations
Check out associations like the Institute of Healthcare Management. They often have job boards, networking events, and conferences that are perfect for connecting with potential employers in health sciences administration.
✨Stay Updated with Industry Trends
Follow health policy news and trends—being knowledgeable about the current landscape will not only help you in interviews but also make you stand out as a candidate. You can discuss recent developments and their implications when chatting with folks at Premier Research.
✨Apply Through Our Website for Better Visibility
When you find roles that excite you, especially at places like Premier Research, don’t forget to apply through our website. This can sometimes give you an edge by showing the employer you’re savvy and committed to finding the right fit.
We think you need these skills to ace Risk Manager - Health
Some tips for your application 🫡
Highlight Your Relevant Experience:When applying for a role in health sciences administration, it's super important to spotlight any relevant experience you have in healthcare settings. Whether you've worked in a hospital, a clinic, or any related environment, make sure to detail those roles in your CV – focusing on your responsibilities and achievements that align with the job at Premier Research.
Showcase Your Administrative Skills:Administrative skills are key in this field, so don’t hold back! Make sure your CV reflects your proficiency in things like scheduling, data management, and compliance with health regulations. Mention specific software you’ve used, such as patient management systems, as this will demonstrate your hands-on abilities and readiness for the role at Premier Research.
Craft a Meaningful Cover Letter:Your cover letter should reflect your passion for the health sciences field and your eagerness to contribute to Premier Research. Share a bit about why you’re drawn to this sector, any impactful situations or challenges you’ve encountered, and how they’ve shaped your desire to work in health sciences administration. This personal touch can really set you apart!
Tailor Your Documents to the Job:Don't use a one-size-fits-all approach! Make sure your CV and cover letter are specifically tailored for this role. Highlight any certifications you have relevant to health administration, and ensure you clearly connect your previous roles to the skills needed for the full-time position at Premier Research. This way, you're showing them you’ve done your homework and are genuinely interested in being a part of their team.
How to prepare for a job interview at Premier Research
✨Showcase Your Administrative Skills
In health sciences administration, being organised is key. Make sure you can demonstrate your skills in managing schedules, paperwork, and data accurately. Be ready to discuss specific tools you've used, like electronic health record systems or scheduling software, and how they improved efficiency in your past experiences.
✨Know Your Regulations
Familiarity with healthcare regulations and compliance is crucial. Brush up on HIPAA, GDPR, or other relevant policies before your interview. We recommend preparing examples of how you've ensured compliance or handled sensitive information in past roles—this will show you're not just knowledgeable but also responsible.
✨Prepare for Scenario Questions
Interviews for administrative roles often involve scenario-based questions to assess your problem-solving skills. Practice responses to common situations you might face, such as dealing with a challenging patient or managing a sudden schedule change. This will not only demonstrate your ability to think on your feet but also highlight your interpersonal skills.
✨Align Your Goals with the Organisation
As a full-time candidate, employers will want to know how your long-term career goals align with their mission. Take some time to research Premier Research’s values and be ready to tie your passion for health sciences administration into their objectives. Demonstrating enthusiasm and career alignment can be a game-changer in this competitive field!
