Description
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.
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 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 levels within the organization 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 fluidly in response to changing project demands.
- Excellent understanding of project protocol, project documentation including centralized monitoring and risk-based monitoring.
- Broad working knowledge of the roles, functions and process of conducting clinical trials.
- Must be able to manage time effectively, working with multiple functions and requirements.
- Must have been involved in the use of trial management or data management systems.
Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.
Our company
The 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.
In this position, you will be eligible for the following perks:
- Permanent full-time position
- Vacation, PPK, health allowance
- Home-based position with teleworking allowance
- Ongoing learning and development
Work location
This position is opened to candidates across Poland (home-based position).
Recruitment process: what to expect
- As part of the recruitment process for this position you will meet various team members at Indero
- The first interview will be conducted by phone (20 minutes) and the second via video conference (1 hour)
- The second interview includes a short presentation for which reasonable advance preparation is required (preparation is not timed and can be completed over a few days). You may think of it as one interview question for which you have the opportunity to develop a strong structured response that goes beyond the surface.
About Indero
Indero is a contract research organization (CRO) specialized in dermatology and rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe.
Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
Indero only accepts applicants who can legally work in Poland.
