Central Risk Manager

Role Overview

• Provides advice and subject matter expertise for the development of the monitoring strategy required for the project and where required, advises the project team on any updates to the monitoring strategy during the study based on risks.
• Works with cross-functional leads to understand complex indications and risks and seeks input on risk mitigations.
• Drafts initial risk assessment, supports the project team in ensuring cross-functional involvement in the finalization of the RACT.
• Ensures PL transfers risks identified to the correct tracking system and supports ongoing cross functional review of risks throughout the project.
• Provides advice on the development of functional plans to ensure identified risks are mitigated.
• Assess tools where available to conduct remote data review and centralized statistical monitoring, identifying risks to data quality and integrity.
• Facilitates review of findings with the internal cross-functional team and sponsor. Requires support from cross-functional leads on complex risks and mitigations.
• With support and where required, collaborates with other team members and Sponsor to identify Quality Tolerance Limits.
• As required, provides development and delivery of initial and ongoing training to the study team regarding the risk assessment, centralized monitoring and the wider risk-based monitoring strategy.
• Coaches and mentors peers regarding functional delivery, evaluation of project risks, and action implementation.
• Collaborates with other functional areas to ensure risks identified in compliance and delivery according to protocol, ICH/GCP and/or Good Pharmacoepidemiology Practices (GPP) and country regulations, including medical monitoring, Safety, Quality Assurance (QA). Ensures Inspection Readiness for risk assessment and centralized monitoring scope.
• Understands the study scope of work, budget and protocol content for their assigned study.
• Escalates to the PM any risk assessment and centralized monitoring deliverables (timeline, quality, and budget) at risk, and any activities and requests which are out of contracted scope.
• May participate in business development activities including monitoring strategy and budget input, defines meetings and proposal development.

Requirements

• Provides advice and subject matter expertise for the development of the monitoring strategy required for the project and where required, advises the project team on any updates to the monitoring strategy during the study based on risks.
• Works with cross-functional leads to understand complex indications and risks and seeks input on risk mitigations.
• Drafts initial risk assessment, supports the project team in ensuring cross-functional involvement in the finalization of the RACT.
• Ensures PL transfers risks identified to the correct tracking system and supports ongoing cross functional review of risks throughout the project.
• Provides advice on the development of functional plans to ensure identified risks are mitigated.
• Assess tools where available to conduct remote data review and centralized statistical monitoring, identifying risks to data quality and integrity.
• Facilitates review of findings with the internal cross-functional team and sponsor. Requires support from cross-functional leads on complex risks and mitigations.
• With support and where required, collaborates with other team members and Sponsor to identify Quality Tolerance Limits.
• As required, provides development and delivery of initial and ongoing training to the study team regarding the risk assessment, centralized monitoring and the wider risk-based monitoring strategy.
• Coaches and mentors peers regarding functional delivery, evaluation of project risks, and action implementation.
• Collaborates with other functional areas to ensure risks identified in compliance and delivery according to protocol, ICH/GCP and/or Good Pharmacoepidemiology Practices (GPP) and country regulations, including medical monitoring, Safety, Quality Assurance (QA). Ensures Inspection Readiness for risk assessment and centralized monitoring scope.
• Understands the study scope of work, budget and protocol content for their assigned study.
• Escalates to the PM any risk assessment and centralized monitoring deliverables (timeline, quality, and budget) at risk, and any activities and requests which are out of contracted scope.
• May participate in business development activities including monitoring strategy and budget input, defines meetings and proposal development.

Tech Stack

• Google Cloud Platform

Benefits

• We are passionate about developing our people, through career development and progression;
• supportive and engaged line management;
• technical and therapeutic area training;
• peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself.