Clinical Risk Manager

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