RBQM Manager _ Office Based

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring recent 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 requiremen

📌 Rbqm Lead Chennai
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📍 Chennai