Senior Central Risk Manager (India)

Description

The Senior Central 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 Central 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.

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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.

Experience

• Minimum of 5 years in risk management within a clinical research setting.
• Over 10 years of experience across clinical monitoring, data management, drug safety, medical monitoring, biometrics, or project management.

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.

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 Innovaderm, 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
• Flexible schedule
• Vacation
• Home-based position
• Ongoing learning and development

About Innovaderm

Innovaderm is a contract research organization (CRO) specialized in dermatology. 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, Innovaderm continues to grow and expand in North America and Europe.