Biomarker Operations Manager
Job Title: Biomarker Operations ManagerLocation: Plainsboro NJDuration: 8+ MonthsQualifications:Support implementation and execution of clinical biomarker and translational sample strategy for projectsSupport sample logistics and operations for clinical and biomarker samples, working closely with CMT team personnel, central laboratories, and specialty lab vendorsExecute assigned operational activities required to manage the lifecycle of biomarker samples (collection, processing, analysis, data delivery and cleaning process, and final sample disposition)As directed, support CMTs during data cleaning process to ensure oversight of biomarker samples, data transfer and reconciliation proceduresAssist with review of lab specifications and manuals as well as sample handling training and collection/processing materials for investigator sites/monitors together relevant internal and external stakeholders and the central labResponsibilities:The Biomarker Operations Manager will work in multidisciplinary international project teams to discover and develop antibody therapeutics. The Biomarker Operations Manager will manage the operations and logistics necessary to execute the scientific strategy for Oncology projects, contributing to the development of ground-breaking new medicines from concept to the market. The successful candidate will be responsible for working closely with the Director, Biomarker Operations and all key stakeholders to ensure the Biomarker Operations function is an integral part of clinical studies moving forward.**Responsibilities**- Working with Clinical Trial Teams (CTTs) and biomarker/translational/Companion Diagnostic research teams to implement and execute the clinical biomarker, translational sample, and companion diagnostic strategy for projects- Managing sample logistics and operations for clinical and biomarker samples, working closely with CTT team personnel, central laboratories, and specialty lab vendors- Planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biomarker samples (collection, processing, analysis, data delivery and cleaning process, and final sample disposition)- Providing biomarker operational expertise and guidance to cross-functional and CTTs- Proactively supporting the CTTs during data cleaning process to ensure oversight of biomarker samples, data transfer and reconciliation procedures- Contributing to the assessment of site and lab feasibility for biomarker sample collection, handling, and storage- Ensuring review of lab specifications and manuals as well as sample handling training and collection/processing materials for investigator sites/monitors together relevant internal and external stakeholders and the central lab- Supporting presentations and trainings of sites and monitors as needed.**Requirements**- Bachelor’s degree or equivalent and 3+ years of industry related experience- Excellent knowledge and understanding of Oncology clinical trials and the role of biomarkers and translational medicine in clinical studies- Extensive knowledge and understanding of clinical research, ICH, GCP, GLP, data management, regulatory and legal issues/processes as they relate to biomarker samples- Proven experience working in teams managing oncology clinical studies within the pharmaceutical/CRO industry- Extensive experience working with sample/biomarker logistics and operations- Experience with SOPs, guidance and work instructions and ability to draft biomarker related documents or sections within these documents- Ability to be proactive, enthusiastic and goal orientated- A team player with demonstrated ability to collaborate with a diverse group of internal and external stakeholders (e.g. Scientists, Trial Managers, Data Managers, Clinicians, vendors labs) to support product development strategy- Strong communication skills - both oral and written Con