RBQM Lead

RBQM Manager _ Office Based

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

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

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

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

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply