Clinical Risk Manager I

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 recognize 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.

• Your ideas influence the way we work, and your voice matters here.

• As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Join us and build your future here.

What you'll be doing:

• ​​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, completes 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.  

• ​Evaluates whether Quality Tolerance Limits (QTLs) should be considered, and if so, leads discussion with required functions to establish initial QTL parameters. 

• ​Confirms the proposed custom monitoring strategy is fit for purpose and risk proportionate.  

• ​Ensures the Central Monitor, if in scope, has the required tools to perform aggregated data reviews via analytics, or other methods. 

• Creates configuration notes for programmers of Clinical Analytics.

• ​Authors the Integrated Quality Risk Management Plan (IQRMP) for assigned studies.  

• ​Serves as a Subject Matter Expert (SME) on Risk Management and Risk Based Monitoring (RBM) activities for assigned studies. 

• ​Supports functional leads in completing functional project plans, ensuring relevant mitigations are captured as expected. 

• ​Supports ongoing cross-functional protocol execution risk reviews through the entire project life cycle.  

• ​Supports Kick Off meetings for new awards and opportunities. 

• ​Ensures inspection readiness related to Risk Management and RBM strategy by maintaining accurate and complete documentation. 

• ​Build knowledge of RBQM processes and share learnings within the team.​ 

What we are searching for:

• ​​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 ICH-GCP, ICH E6 (R2 + R3) Guidelines and RACT tools, preferred.  

• ​ Subject matter expertise on RBQM, KRI, QTLs, QbD, Centralized Monitoring, Budgeting and Contracts  

• ​Understands the key concepts of RBQM, Key Risk Indicators (KRI), Quality Tolerance Limits (QTLs), Quality by Design (QbD), Clinical, Centralized Monitoring and budget. 

• ​ 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 leverages data visualizations for decision making.  

• ​ Experience of collaborating with cross-functional global team for solving complex problem  

• ​ Excellent verbal and written communication skills  in English

• ​ Ability to travel up to 20% for sponsor meetings.