Provide Quality Assurance support at site for the Post Launch team, Clinical team, in the Product Lifecycle team and for respective medical services which fall under GxP. Closely collaborate with the Lifecycle business partners to ensure GxP compliance and provide quality oversight for the respective service scope of the clinical trials. Support the implementation of a risk based quality management process fully embedded into the clinical trial service delivery including all vendor managed business setups with the objective of achieving the highest data quality standards, full adherence to patient’s rights and well-being and in support of successful Health Authority inspections. Provide operational QA support to the lifecycle clinical team, including quality oversight for Health Authority commitments, critical incidents including respective escalation process and the implementation of CAPAs for the respective business areas. Act as QA contact to the customer QA organization in line with established quality agreements.
-Drive the implementation of the quality requirements within the lifecycle clinical team. Monitor and track implementation of the annual Quality Plan deliverables together with the supported CT including the quality risk assessments and inspection readiness components for the designated trials.
-Provide Quality input and oversight for the execution of clinical trials or respective services under the responsibility of Lifecycle.
-Lead the quality requirement assessment for new services in close collaboration with the business teams.
-Lead the clinical part of the local Quality Review Board to ensure appropriate management review of all quality and compliance related topics including the review of key quality indicators; identify appropriate continuous improvement initiatives for quality and compliance related areas.
-Support strategic Clinical Quality and Business initiatives, including the design and implementation of respective quality and compliance activities and affected changes, the support of remediation programs and the development and implementation of strategic process improvement.
-Facilitate effective communications within the Clinical team and by interacting with other QA functions and the customer QA in line with established quality agreements.
Ensure that applicable lifecycle clinical processes are implemented in line with the service scope. Help to establish in-built controls in relevant process steps to ensure adherence to regulatory compliance.
-Monitor effectiveness of implementation of applicable clinical processes through KQIs in collaboration with business process owners to demonstrate that processes are in control and ensure required compliance levels.
-Implement and lead the process to regularly review and assess KQIs at the respective Clinical teams. Ensure that potential gaps and risks are addressed and opportunities for continuous improvement identified.
-Ensure and provide effective Quality oversight and management for the following areas:
- Adequate and timely escalation of incidents/issues within Clinical teams and QA.
- Timely and effective initiation of investigations
- Definition of adequate CAPAs are defined, their implementation and effective closure tracked
- Qualification and management of vendors for outsourced activities