Senior Risk Manager (Spain)

BlueSnap, Inc; Santander; Presencial; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

A leading clinical research organization is seeking a Senior Risk Manager to enhance risk-based monitoring strategies within clinical trials. This role involves collaboration with cross-functional teams to assess and mitigate risks, ensure data integrity, and uphold regulatory compliance. Ideal candidates will have significant experience in risk management, excellent analytical skills, and the ability to foster team collaboration.

Servicios

Ongoing learning and development opportunities

Formación

• Minimum of 5 years in risk management in clinical research.
• Expertise in Good Clinical Practice / ICH E6 Guidelines.
• Proficiency in Risk-Based Monitoring strategies and tools.

Responsabilidades

• Develop and execute risk-based monitoring strategies.
• Collaborate with teams to identify and mitigate risks.
• Draft risk assessments and support Risk Assessment Tools.

Conocimientos

Analytical Skills

Communication

Negotiation

Leadership

Educación

Bachelor’s degree in clinical research

Master’s degree in health data sciences

Herramientas

MS Excel

Data visualization tools

Web-based RACT tools

Descripción del empleo

The Senior 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.

Specifically, the Senior Risk Manager must :

• Provide subject matter expertise for developing and updating the risk-based monitoring strategy tailored to project needs.
• Collaborate with cross-functional teams to identify and mitigate risks associated with complex indications.
• Draft initial risk assessments and support the finalization of Risk Assessment and Categorization Tools (RACT).
• Guide Project Managers (PMs) in transferring identified risks to the appropriate tracking systems and ensure ongoing reviews.
• Advise on developing functional plans to mitigate risks effectively.
• Utilize available tools to conduct remote data reviews and centralized statistical monitoring, identifying risks to data quality and integrity.
• Facilitate internal and sponsor reviews of findings, seeking cross-functional support for complex risks and mitigations.
• Deliver initial and ongoing training for study teams on risk assessment, centralized monitoring, and risk-based monitoring strategies.
• Mentor peers and train new team members on functional delivery, risk evaluation, and action implementation.
• Escalate risks or deliverables at risk to the PM, including scope changes.
• Provide strategic input on risk characterization and reporting to leadership.
• Take on additional responsibilities as required, ensuring qualifications and training align with assigned tasks.

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.

Requirements

Qualifications

• Bachelor’s degree in a field relevant to clinical research; Master’s degree or health data sciences degree preferred.
• Expertise in Good Clinical Practice / ICH E6 (R3) Guidelines and other regulatory requirements.
• Proficiency in Risk-Based Monitoring strategies, processes, and tools.

Technical Skills

• Mastery of MS Excel (sorting, filtering, pivot tables).
• Advanced skills in analytical data visualization tools.
• Knowledge of Lean Six Sigma and web-based RACT tools.

Core Competencies

• Strong analytical and statistical understanding.
• Excellent communication, negotiation, and leadership skills.
• Ability to anticipate critical issues and develop proactive contingency plans.
• Skilled in project workflows and cross-functional collaboration.
• Training, mentoring, and organizational capabilities.

Experience

• Minimum of 5 years in risk management within a clinical research setting.
• Minimum of 7 years of experience across clinical monitoring, data management, drug safety, medical monitoring, biometrics, or project management.

Attributes

• Fluent in English (excellent oral and written).
• Must be able to communicate clearly and effectively at all organizational levels and with external customers.
• Must be a fast learner and able to understand new concepts quickly.
• Prioritization skills with the ability to plan, monitor, and manage workload responsively.
• Excellent understanding of project protocols, documentation, centralized monitoring, and risk-based monitoring.
• Broad knowledge of clinical trial functions and processes.
• Ability to manage time effectively while working with multiple functions.
• Experience with trial management or data management systems.

Good knowledge of GCP, Health Canada, and FDA regulations / guidelines.

Our Company

The Work Environment

At Indero, you will collaborate with talented colleagues in an environment that values collaboration, innovation, reliability, and responsiveness. We offer a stimulating workplace and opportunities for advancement.

In this position, you will be eligible for :

• Ongoing learning and development opportunities

About Indero

Indero is a CRO specializing in dermatology and rheumatology. Established in 2000, we are known for high-quality research and exceeding client expectations. Based in Montreal, we continue to grow across North America and Europe.

Indero is committed to equitable treatment and providing accommodations during the recruitment process for applicants with disabilities upon request.

Applicants must be legally eligible to work in Spain.

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