RBQM Lead

RBQM Manager _ Office Based

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

Recognize, exemplify and adhere to ICON's values which center on Integrity, Inclusion, Agility and Collaboration:

May include the following in collaboration with PM and cross functional leads, depending on study/ partnership assignments:

During set-up – study award to FPR + 3 months

• Authoring of RBQM plan
• Identification and documentation of CtQ
• Identification and documentation of critical data and processes
• Facilitation of the initial risk assessment process and meetings
• Ensuring on time and high-quality risk assessment completion
• Review critical data path /data flow in association with Clinical data science lead
• Review of critical data review methods in association with Clinical data risk analyst who is the author and owner of DRP.
• Input and review of Risk based monitoring strategy- T-SDV/T-SDR, reduced SDV/SDR in collaboration with CTM
• Review/input into QTLs
• Review/input into central monitoring Key risk indicators
• Quality Gate - Review/input into all applicable Fucntional plans to ensure risk mitigations are appropriately covered.
• Initiate ongoing risk reviews
• Initiate QRRM

During Maintenance –

Quarterly- Operational Quality review checks to ensure:

Proactive identification, resolution/mitigation, and escalation of study level risks and/or issues- QRRM output

Monitoring strategy is operationalized as per plan and in alignment with budget

Periodic Risk assessments as required by changes to critical data or risks or change in milestone or protocol amendments

Input into division or program-level oversight, quality and compliance processes related to RBQM requirements.

study level reviews of quality related data, to identify trends and potential risks, including:

• Project non-conformance trending
• CAPA trending (project and site level CAPAs)
• Critical and Major audit & inspection findings (study and site level)
• Present review output to PM and FTLs, collaborating with them on the identification of risks, proposing potential risk mitigations and actions
• Report to Governance and oversight dashboard as per plan
• Serves as a point of escalation

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

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