Senior Risk Manager (Spain)

BlueSnap, Inc; Lugo; Presencial; EUR 50.000 - 80.000; Jornada completa

Descripción de la vacante

A leading CRO specializing in dermatology is seeking a Senior Risk Manager. You'll be pivotal in developing risk-based monitoring strategies, collaborating across teams to ensure the integrity of clinical trial data. This role requires extensive experience in clinical research, strong analytical skills, and excellent communication. Join us to support innovative clinical projects and advance your career within a dynamic team dedicated to high-quality research.

Servicios

Ongoing learning and development opportunities

Formación

• Fluent in English, both verbal and written.
• Minimum of 5 years in risk management within clinical research.
• Extensive experience in clinical monitoring and data management.

Responsabilidades

• Develop risk-based monitoring strategies and risk assessments.
• Collaborate across teams to manage risks in clinical trials.
• Deliver training on risk assessment and monitoring strategies.

Conocimientos

Analytical skills

Communication

Leadership

Negotiation

Educación

Bachelor’s degree in clinical research

Master’s degree or health data sciences degree

Herramientas

MS Excel

Data visualization tools

Lean Six Sigma 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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