Central Risk Manager

This is a fully remote position, open to applicants in Philippines.

📋 Description

• Offers guidance and subject matter expertise for formulating the monitoring strategy needed for the project, and advises the project team on any necessary updates to the monitoring strategy during the study based on identified risks.

• Collaborates with cross-functional leads to comprehend complex indications and risks while seeking input on risk mitigation strategies.

• Prepares the initial risk assessment and assists the project team in ensuring cross-functional participation in finalizing the RACT.

• Guarantees that the Project Lead (PL) transfers identified risks to the appropriate tracking system and facilitates ongoing cross-functional evaluation of risks throughout the project's duration.

• Offers counsel on developing functional plans to ensure that identified risks are effectively mitigated.

• Evaluates tools available for conducting remote data reviews and centralized statistical monitoring, pinpointing risks to data quality and integrity.

• Coordinates the review of findings with internal cross-functional teams and sponsors, requiring assistance from cross-functional leads on intricate risks and mitigations.

• Collaborates with team members and sponsors, as necessary, to establish Quality Tolerance Limits.

• Provides initial and ongoing training to the study team regarding risk assessment, centralized monitoring, and the broader risk-based monitoring strategy, as required.

• Coaches and mentors colleagues on functional delivery, project risk evaluation, and the implementation of actions.

• Works with other functional areas to ensure that risks are identified in compliance with protocols, ICH/GCP, and/or Good Pharmacoepidemiology Practices (GPP), as well as country regulations, including medical monitoring, safety, and Quality Assurance (QA). Ensures readiness for inspections regarding risk assessment and centralized monitoring scope.

• Possesses an understanding of the study's scope of work, budget, and protocol content for their assigned study.

• Alerts the Project Manager (PM) to any risk assessment and centralized monitoring deliverables (timeline, quality, and budget) that are at risk, along with any activities and requests that fall outside the contracted scope.

• May engage in business development activities, including contributing to monitoring strategies and budgets, as well as defining 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.

🏝️ 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.