ppPremier Research is looking for a Clinical Risk Manager I to join our Global Clinical Strategy and Delivery team. /ppYou 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. /ppWe 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. /ppYour ideas influence the way we work, and your voice matters here. /ppAs an essential part of our team, you help us deliver the medical innovation that patients are desperate for. /ppJoin us and build your future here. /ph3What you'll be doing: /h3ulliSupport Clinical Bidder, Proposals and Business Development by providing the rationale for the overarching monitoring strategy based on initial risk assessment, as needed. /liliUpon 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. /liliEvaluates whether Quality Tolerance Limits (QTLs) should be considered, and if so, leads discussion with required functions to establish initial QTL parameters. /liliConfirms the proposed custom monitoring strategy is fit for purpose and risk proportionate. /liliEnsures the Central Monitor, if in scope, has the required tools to perform aggregated data reviews via analytics, or other methods. /liliCreates configuration notes for programmers of Clinical Analytics. /liliAuthors the Integrated Quality Risk Management Plan (IQRMP) for assigned studies. /liliServes as a Subject Matter Expert (SME)



on Risk Management and Risk Based Monitoring (RBM) activities for assigned studies. /liliSupports functional leads in completing functional project plans, ensuring relevant mitigations are captured as expected. /liliSupports ongoing cross-functional protocol execution risk reviews through the entire project life cycle. /liliSupports Kick Off meetings for new awards and opportunities. /liliEnsures inspection readiness related to Risk Management and RBM strategy by maintaining accurate and complete documentation. /liliBuild knowledge of RBQM processes and share learnings within the team. /li /ulh3What we are searching for: /h3ulliBachelors in Biological S ciences, H ealth S ciences and/or related disciplines in the health care domain. /liliSignificant 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. /liliSubject matter expertise on RBQM, KRI, QTLs, QbD , Centralized Monitoring, Budgeting and Contracts /liliUnderstands the key concepts of RBQM, Key Risk Indicators (KRI), Quality Tolerance Limits (QTLs), Quality by Design ( QbD ), Clinical, Centralized Monitoring and budget. /liliExcellent analytical, computational, judgement and decision-making ability /liliStrong fundamental understanding of statistical concepts, statistical analysis techniques and Integrated Quality Risk Management (IQRM) theories /liliLead process improvement initiatives at department/organizational level /liliExpertise with MS Excel, Business Intelligence tools and leverages data visualizations for decision making. /liliExperience of collaborating with cross-functional integral team for solving complex problem /liliExcellent verbal and written communication skills in English /liliAbility to travel up to 20% for sponsor meetings. /li /ul /p #J-18808-Ljbffr

📌 Clinical Risk Manager I (España)
🏢 PVH (Tommy Hilfiger/Calvin Klein)
📍 España