Risk Manager - Spain

<h3>Description</h3> <p>The Risk Manager plays a pivotal role in developing and executing risk-based monitoring strategies, ensuring data quality and integrity in clinical research projects. This position involves cross-functional collaboration to identify, assess, and mitigate risks throughout the clinical trial lifecycle, supporting the seamless implementation of Risk-Based Study Management (RBSM) principles.   </p><p><br/></p><p><strong>RESPONSIBILITIES</strong></p><p>More specifically, the Risk Manager must: </p><ul><li>Provide subject matter expertise for developing and updating the risk-based monitoring strategy tailored to project needs. </li><li>Collaborate with cross-functional teams to identify and mitigate risks associated with complex indications. </li><li>May have to coordinate with central monitor team and verify work. </li><li>Point sur provide budget recommendations, change orders. </li><li>Draft initial risk assessments and support the finalization of Risk Assessment and Categorization Tools (RACT). </li><li>Guide Project Managers (PMs) in transferring identified risks to the appropriate tracking systems and ensure ongoing reviews. </li><li>Advise on developing functional plans to mitigate risks effectively. </li><li>Utilize available tools to conduct remote data reviews and centralized statistical monitoring, identifying risks to data quality and integrity. </li><li>Facilitate internal and sponsor reviews of findings, seeking cross-functional support for complex risks and mitigations. </li><li>Deliver initial and ongoing training for study teams on risk assessment, centralized monitoring, and risk-based monitoring strategies. </li><li>Escalate risks or deliverables at risk to the PM, including scope changes. </li><li>Provide strategic input on risk characterization and reporting to leadership. </li><li>Take on additional responsibilities as required, ensuring qualifications and training align with assigned tasks. </li></ul><p>Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training.</p><p><br/></p> <h3>Requirements</h3> <p>Education</p><ul><li>Bachelor’s degree in a field relevant to clinical research;  </li></ul><p>Experience</p><ul><li>Minimum of 3 years in risk management within a clinical research setting. </li><li>Minimum 5 years of experience across clinical monitoring, data management, drug safety. </li></ul><p>Requirements:</p><ul><li>Expertise in Good Clinical Practice/ICH E6 (R3) Guidelines and other regulatory requirements. </li><li>Proficiency in Risk-Based Monitoring strategies, processes, and tools. </li><li>Mastery of MS Excel (sorting, filtering, pivot tables). </li><li>Advanced skills in analytical data visualization tools. </li><li>Knowledge of Lean Six Sigma and web based RACT tools. </li><li>Strong analytical and statistical understanding. </li><li>Excellent communication, negotiation, and leadership skills. </li><li>Ability to anticipate critical issues and develop proactive contingency plans. </li><li>Skilled in project workflows and cross-functional collaboration. </li><li>Training, mentoring, and organizational capabilities. </li><li>High level of autonomy. </li><li>Fluent in English (excellent oral and written).   </li><li>Must be able to communicate clearly and effectively at all levels within the organization and with external customers. </li><li>Must be a fast learner and able to understand new concepts quickly. </li><li>Prioritization skills with the ability to plan, monitor, and manage workload fluidly in response to changing project demands. </li><li>Excellent understanding of project protocol, project documentation including centralized monitoring and risk-based monitoring. </li><li>Broad working knowledge of the roles, functions and process of conducting clinical trials. </li><li>Must be able to manage time effectively, working with multiple functions and requirements. </li><li>Must have been involved in the use of trial management or data management systems. </li></ul><p>Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.</p> <h3>Our company</h3> <p><strong>The work environment</strong></p><p><strong> </strong></p><p>At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. </p><p><strong> </strong></p><p><strong>In this position, you will be eligible for the following perks: </strong></p><ul><li>Permanent full-time position</li><li>Vacation, PPK, health allowance</li><li>Home-based position with teleworking allowance</li><li>Ongoing learning and development <strong> </strong></li></ul><p><strong> </strong></p><p><strong>About Indero</strong></p><p>Indero is a contract research organiz