Senior Clinical Study Manager
Ensure that global regulated clinical studies are compliant and that clinical trials are conducted with company goals, SOPs, Ethics, ICH GCP and global regulatory guidelines. Provide operations management for the planning, execution and reporting of Phase III global clinical trials. Work within the pharmaceutical industry practices and standards for new drug development and therapeutic area in various indications, with particular focus on early development of oncology drugs in a complex setting. Work on strategic planning and critically assess the global clinical development plans, protocol design, resources needs, global budgets and timelines for programs. Apply applicable clinical research regulatory requirements. Work on Clinical Trials Management, Clinical Project Management, Clinical Trials Remote Monitoring and Risk based monitoring (RBM). Involved with sponsor oversight of adverse event reporting, safety reporting and pharmacovigilance requirements required for global clinical trials and sponsor oversight of clinical data analysis, clinical data interpretation, statistical analysis and clinical data verification and data integrity. Perform financial budgeting, negotiation and forecasting for global clinical trials. Manage overall clinical study quality and compliance. Requires B.S. degree in the life sciences field plus 5 years of experience in clinical research and extensive knowledge of clinical drug development and clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines; understanding of drug development process from Phase I, II, III, IV clinical trials through filing; familiarity with advanced concepts of clinical research; understanding of the pharmaceutical industry practices and standards for new drug development; understanding of Contract Research Organization (CRO) and vendor management; knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, US Food and Drug Administration (FDA), FDA CFR, European and International guidelines, PhRMA code, clinical research ethics, HIPAA and patient privacy laws, EU Directive. Requires Clinical Research Associate (CCRA) Certification and Project Management for Professionals Certification. Job located in South San Francisco, CA.
Resume to: LSK BioPartners, Attn: Angie Price, 400 Oyster Point Blvd., Suite 226, So. San Francisco CA 94080.