This position will be responsible for GCP/Clinical Quality Assurance activities. The primary responsibilities will be to ensure to quality and compliance of Madrigal-sponsored clinical trials with applicable GCP regulations, ICH GCP guidelines, Madrigal SOPs, and current industry standards and best practices. This position reports into the Senior Director, GCP Quality.
Responsibilities:Ensure clinical trial activities are compliant with ICH and applicable country regulations and guidelines and industry standardsAlign organization to ICH in implementing a quality culture from the outset of clinical trials to promote patient safety and data integrityApply a risk-based approach by working collaboratively cross-functionally to ensure compliance Attend routine internal, external study team and ad hoc calls in support of ongoing quality oversight Engage partnership with external vendors via adherence to Quality Agreements and routine meetingsCoordinate reviews, management documentation, track and/or follow-up on internal Quality Event investigations, deviations, Observations/Findings, CAPAs, etc.
to ensure closureSupport the use of an eQMS via data entry/document upload of quality activities (audits, observations, inspections, CAPAs, SOP Deviations, QEs/Investigations) and SOP updatesContribute to the annual audit plan Assure through Qualification audits and oversight activities that clinical trial vendors are operating in compliance with all applicable procedures, study documents, regulations/guidelines May review vendor MSA or contract/Work OrdersConduct or manage internal/external audits (vendor, site, document, system or process) and prepare or review audit reportsCoordinate and manage services provided by external QA vendorsReview key documents, such as IB, Protocols/Amendments, Consents, TMF PlansInform and escalate to management in real-time or during routine updates, as appropriateParticipate in inspection readiness activities or provide support during global agency inspectionsConduct other tasks in support of GCP Quality activities, (e.g., chase training assignments, request contracts) Stay abreast of applicable global regulations, guidances, and industry best practicesQualifications:
Overall qualification by experience to support the responsibilities not limited to those outlined aboveDemonstrated GCP knowledge, GLP/GVP knowledge a plusSolid understanding of the cross-functional drug development process including specific to clinical trial operations, data management, statistics, etcSkilled in developing collaborative internal and external relationshipsBusiness and Operational acumen to include escalation to managementAbility to interact with all levels within an organizationExperience in inspection preparation or supporting regulatory agency inspectionsExperience in using eQMS systems, such as VeevaBS in a scientific or other relevant discipline with equivalent work experienceApply for this job
