Job Description
The Risk Surveillance Lead is a critical role responsible for driving the adoption of Quality Management practices at trial level and overseeing implementation, and continuous improvement. The Risk Surveillance Lead works within a matrix environment and has overall accountability for the surveillance of quality risks across assigned trials and programs, enabling comprehensive clinical quality risk governance.
The role demonstrates leadership in influencing and improving clinical trial quality through expert understanding of clinical trial protocols, processes, regulatory requirements, and quality management principles. This role can be based in our offices in Dublin, Ireland or Barcelona, Spain. On-site expectation of three days in the office.
Key Responsibilities:
* Facilitate trial protocol risk assessment across multiple cross-functional domains (clinical, operational, data management, vendors, regulatory etc.) associated to critical-to-quality (CtQ) data and processes, including definition of quality tolerance limits (QTLs), evaluation of risks based on likelihood, detectability, impact, and ensures mitigation strategy / plans are defined.
* Responsible for drafting, maintaining, and archiving the study specific documentation of risk management activities e.g., Integrated Quality Risk Management Plan (IQRMP).
* Partners with the Quality Management system configuration team to ensure risk indicators, quality tolerance limits and other analytics/visualizations are programmed and functioning per operational requirements in the Quality Management system.
* Conduct of periodic central surveillance of the aggregate data at the study and potentially program level, leveraging available analytics/visualizations in the Quality Management system, to identify emerging risks and/or issues.
* Facilitate risk review meetings and discussions with study and potentially program team members to effectively communicate and discuss the findings, support, and encourage robust root cause identification and mitigation strategies.
* Supports and participates in internal and external audits and inspection.
* Collaborate with training departments to support training initiatives and aid in the adoption of the Quality Management approach.
Benefits include working with a global organization committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Why this role?
This role offers a unique opportunity to drive innovation and excellence in Quality Management, collaborating with talented professionals to make a meaningful impact on patients' lives.