Clinical Risk Manager I

46 Premier Research Group SL; España; Presencial; EUR 90.000 - 120.000; Jornada completa

Descripción de la vacante

Premier Research is seeking a Clinical Risk Manager I to join the Global Clinical Strategy and Delivery team. You will help biotech, medtech and specialty pharma transform ideas into medicines, devices and diagnostics, ensuring RBM readiness and risk-based monitoring across studies.

Leading the monitoring strategy, you will collaborate with cross-functional teams, manage IQRMP, and act as SME in RBM activities. This role requires English communication and up to 20% travel.

Formación

• Bachelor in Biological Sciences, Health Sciences and/or related disciplines in the health care domain.
• 8+ years of clinical research experience related to RBQM, Central Monitoring and Project Management.
• Subject matter expertise on ICH-GCP, ICH E6 (R2 + R3) Guidelines and RACT tools preferred.
• RBQM, KRI, QTLs, QbD, Centralized Monitoring, Budgeting and Contracts knowledge.
• Understanding of RBQM concepts including KRIs, QTLs and IQRM theories.
• Strong analytical, computational, judgement and decision-making abilities.
• Experience collaborating with cross-functional global teams.
• Excellent verbal and written communication skills in English.

Responsabilidades

• Support the overarching monitoring strategy based on initial risk assessment.
• Complete the study RACT and identify Critical Data and Critical Processes.
• Lead discussions to establish QTL parameters when applicable.
• Ensure proposed monitoring strategies are fit for purpose and risk proportionate.
• Provide tools and configuration notes for Clinical Analytics programmers.
• Authors Integrated Quality Risk Management Plans (IQRMP) for studies.
• Serve as SME on Risk Management and RBM activities.
• Support cross-functional project plans and risk reviews throughout life cycle.

Conocimientos

Analytical skills

English proficiency

Cross-functional collaboration

Educación

Bachelor's degree in Biological Sciences

Herramientas

MS Excel

Business Intelligence tools

Data visualization

Descripción del empleo

Premier Research is looking for a Clinical Risk Manager I to join our Global Clinical Strategy and Delivery 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 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.

Premier Research is more than a company - it's a community furthering research to improve the lives of patients in critical need. We are a diverse staff thinking creatively, challenging ideas, and solving complex problems.

Our Values - We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care - mirror the determination, flexibility and trust that our team embodies.

As a Premier team member, you have the power to make an impact, regardless of job title and location. Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning.

Premier Research is a global clinical research, product development, and consulting company.

We are dedicated to helping biotech, specialty pharma, and MedTech innovators transform life-changing ideas and breakthrough science into new medical treatments.

Our team is inspired by this common purpose.

Premier is a place where you can change lives, and feel rewarded and celebrated.

We aim high - we will not stop until we reach our goals. And we care about each other, about our customer and partners, and, most importantly, about all the patients that we touch with our work.