• Serves as Clinical Quality lead for clinical trial programs. • Ensures compliance of clinical studies with internal SOPs and clinical plans as well as with applicable worldwide regulations and guidelines to ensure adherence to GCP in conduct of clinical trials and the quality and integrity of generated data. • Evaluates, writes and/or reviews documentation generated by internal or external parties (e.g. SOPs, Essential documents, Clinical Plans) • Contribute to the with the establishment, development and day to day management of a cross company GxP quality management system including document control, risk management and CAPA management. Ensure clinical quality requirements are fit for purpose and are appropriate to the clinical phase. • Assists with the selection and leads the qualification process for selected external vendors and with Clinical Operations provides oversight for outsourced contracted clinical activities. • Establishes audit plans and leads, participates or manages (via consultants) audits (and follow up of action plans) including internal, vendors, clinical sites, external laboratories, suppliers. • Quality supports for supply chain activities related to the procurement of starting material and delivery of final product. • Provides support to establish fit for purpose practices that ensure traceability and data integrity for internal laboratories in particular those analysing clinical patient samples • Provide GCP/GCLP/GLP guidance as appropriate to clinical project teams, including risk identification/mitigation of potential of identified operational issues/deviations. • Identifies and monitor quality indicators and data to identify potential trends and risks to patient safety, compliance, data integrity or to the business and promote improvements. • Participate in project meetings (internal and external) as Clinical Quality representative. • Planning and implementing regular GCP training and other quality related clinical training •
