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Position: Senior Risk Manager

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.

More 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.

Company and Work Environment

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.

Perks include:

• Permanent full-time position
• Vacation, PPK, health allowance
• Home-based position with teleworking allowance
• Ongoing learning and development

Location and Recruitment

This position is open to candidates across Poland (home-based).

Recruitment process:

• Initial phone interview (20 minutes)
• Follow-up video interview (1 hour) with a short presentation to prepare

About Indero

Indero is a CRO specializing in dermatology and rheumatology, established in 2000, with a reputation for high-quality research and services. Based in Montreal, we are expanding in North America and Europe.

We are committed to equitable treatment and provide accommodations for applicants with disabilities upon request. Only applicants legally authorized to work in Poland will be considered.

Qualifications

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

Technical Skills

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

Core Competencies

• Strong analytical and statistical skills.
• Excellent communication, negotiation, and leadership abilities.
• Proactive in issue anticipation and contingency planning.
• Experience with project workflows and cross-functional collaboration.
• Training, mentoring, and organizational skills.

Experience

• At least 5 years in risk management within clinical research.
• At least 7 years in clinical monitoring, data management, drug safety, or related fields.

Attributes

• Fluent in English, both oral and written.
• Effective communicator at all organizational levels.
• Quick learner, capable of understanding new concepts rapidly.
• Excellent prioritization and workload management skills.
• Knowledge of clinical trial protocols, documentation, and systems.

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