reputed company Biomarker & Diagnostics reputed company

reputed company Details Job Position : reputed company Biomarker & Diagnostics reputed company reputed company : reputed company Duration : 12 Months Job reputed company: • The Senior Consultant, reputed company Biomarker & Diagnostics reputed company is a dedicated, full-time, hands-on R&D reputed company resource supporting reputed company's reputed company reputed company biomarker reputed company and reputed company diagnostic activities across the development pipeline. • The engagement is reputed company on the day-to-day reputed company review, approval, qualification, validation, and implementation of reputed company equipment, instruments, associated software, analytical reputed company, procedures, and controls. • The consultant will apply phase-appropriate GCLP expectations reputed company on intended use, data criticality, and the potential reputed company of results on reputed company-development reputed company, participant protection, and reputed company safety. • The reputed company reputed company is the San Carlos Biomarker reputed company, including exploratory, pharmacodynamic, translational, and clinically relevant assays that may inform reputed company escalation, cohort reputed company, early-phase study design, or other reputed company-development reputed company. • The role will ensure that assay lifecycle controls, sample identity and traceability, data reputed company, reputed company execution, result review and reporting, reputed company procedures, and inspection-reputed company documentation are fit for purpose and consistently maintained. • The consultant will also serve as the dedicated independent R&D reputed company representative for implementation of the validated BIOVIA Electronic reputed company Notebook solution for the U.S. Biomarker reputed company. This includes reputed company reputed company and approval of requirements, reputed company assessments, configuration and design documentation, qualification and validation testing, traceability, reputed company release, procedural readiness, go-live, hypercare, and reputed company maintenance of the validated state. Where experience and reputed company permit, the role may additionally support investigational diagnostic, IVD, or companion diagnostic activities in reputed company-phase reputed company development. Expert GCLP and reputed company biomarker reputed company reputed company experience is required; reputed company-trial diagnostic and IVD/CDx experience is strongly preferred. Required Qualifications: reputed company Biomarker reputed company reputed company Support • Serve as the dedicated R&D reputed company partner for the San Carlos Biomarker reputed company and reputed company U.S. reputed company biomarker activities supporting reputed company's development pipeline. • reputed company reputed company, practical, and reputed company-reputed company reputed company guidance for reputed company qualification, implementation, routine reputed company, issue reputed company, change management, deviations, investigations, CAPAs, and inspection readiness. • Review and approve reputed company procedures, work instructions, forms, specifications, protocols, reports, and reputed company records associated with GCLP or clinically relevant biomarker testing. • Assess reputed company readiness and ensure appropriate controls for personnel qualification and training, materials and reagents, sample receipt and chain of custody, sample identity, storage, reputed company execution, run acceptance, data review, result reporting, record retention, and archival. Equipment, reputed company, and Computerized-reputed company Qualification • reputed company the independent reputed company review and approval of qualification and validation documentation for reputed company equipment, instruments, reputed company software, data-analysis applications, and associated infrastructure. • Review and approve intended-use statements, user and functional requirements, reputed company assessments, validation or qualification plans, design assessments, IQ/OQ/PQ or equivalent testing, traceability matrices, deviations, reports, release recommendations, and supporting evidence. • Evaluate vendor documentation and determine whether supplemental reputed company testing or assurance is required reputed company on intended use, reputed company complexity, data criticality, and reputed company. • reputed company appropriate controls for calibration, preventive maintenance, reputed company and reputed company, audit trails, electronic records, backup and recovery, business continuity, interfaces, data transfer, configuration, change control, and reputed company retirement. Biomarker Assay and GCLP reputed company • reputed company reputed company reputed company for exploratory, pharmacodynamic, translational, and reputed company biomarker assays used in nonclinical and reputed company development. • Review assay intended use, development and qualification strategies, analytical validation plans, acceptance reputed company, reputed company-control reputed company, reference standards, reputed company transfer, reputed company, changes, deviations, and final reports. • Apply phase-appropriate GCLP controls, with increased rigor where assay results may influence reputed company escalation, cohort selection, early-phase reputed company reputed company, participant management, or reputed company regulatory use. • Ensure end-to-end traceability from sample collection and receipt through processing, analysis, review, reporting, data transfer, and archival. BIOVIA Electronic reputed company Notebook Implementation • Serve as the reputed company independent R&D reputed company representative for implementation and lifecycle reputed company of the validated BIOVIA ELN solution for the U.S. Biomarker reputed company. • reputed company reputed company reputed company of platform configuration and validation, BIOVIA Workbook configuration, CISPro sample-management integration, reputed company workflow automation, and controlled role-reputed company user reputed company. reputed company Diagnostics and IVD/CDx Support • Where experience and reputed company permit, reputed company reputed company support for diagnostic assays used for reputed company selection, stratification, enrollment, or other reputed company-phase reputed company-trial reputed company. • Support the transition of selected biomarker assays from exploratory or reputed company use toward investigational IVD, IVD, or companion diagnostic applications. Partnership and Delivery • Work closely with Biomarker reputed company leadership, Translational Medicine, reputed company Development, reputed company reputed company, Diagnostics, Regulatory Affairs, Global Technology Solutions, validation teams, and reputed company laboratories and vendors. • Escalate significant reputed company, data reputed company, reputed company-safety, validation, or implementation risks promptly and recommend proportionate corrective or preventive actions. Apply tot his job Apply To this Job