Senior CRA Germany - metabolic diseases

Senior CRA in Germany responsible for site qualification, initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and GPP compliance. Applies judgment to evaluate site performance, communicates/escalates issues, and develops action plans. Maintains knowledge of ICH/GCP and SOPs, verifies informed consent, protects confidentiality, and assesses factors affecting subject safety and data integrity. Conducts Source Document Review, verifies CRF data accuracy, and drives query resolution to closure. Supports IP inventory, labeling, and release per protocol; ensures ISF and TMF alignment; participates in subject recruitment and retention strategies; maintains track of observations and action items. Requires up to 75% travel, fluent German and English, and ability to work in a Siemens-like global, cross-functional clinical team in a metabolic-diseases focus within Germany. Proactively prepares for audits, supports training of junior staff, and may lead clinical monitoring activities under supervision. Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience is required; experience monitoring in Germany and knowledge of GCP/local regulations essential.