[Hiring] Risk Manager @Indero

Role Description

The Risk Manager (Clinical Research) 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 in a CRO or pharma industry.

Responsibilities

• 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.
• Coordinate with central monitor team and verify work.
• Provide budget recommendations and change orders.
• 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.
• 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.

Qualifications

• Bachelor’s degree in a field relevant to clinical research.
• Must have experience in a CRO or pharma industry.
• Minimum of 3 years in risk management within a clinical research setting.
• Minimum 5 years of experience across clinical monitoring, data management, drug safety.

Requirements

• Expertise in Good Clinical Practice/ICH E6 (R3) Guidelines and other regulatory requirements.
• Proficiency in Risk-Based Monitoring strategies, processes, and tools.
• 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.
• 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.
• High level of autonomy.
• 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.

Benefits

• Flexible work schedule.
• Permanent full-time position.
• Ongoing learning and development.

Company Description

Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.

• Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery.
• Our full-service approach includes everything from protocol design and patient recruitment to trial monitoring and biometrics.
• Indero is committed to providing equitable treatment and equal opportunity to all individuals.
• Indero only accepts applicants who can legally work in Romania.