Senior Central Risk Manager (India)


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.

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.

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