Karl Bean Email & Phone Number

Yorba Linda, Ca, Us

Menlo Park, California, Us

Guiding early to mid-phase clinical trials of non-muscle invasive bladder cancer using proliposomal chemotherapeutic treatments . LIPAC Oncology is a forward-thinking pharmaceutical company focused on clinical development of unique, locally delivered taxane technologies targeting areas of unmet need in Bladder Cancer, Upper Tract Urothelial Carcinoma, Stage II/III Ovarian Cancer, Intraperitoneal Carcinoma and Mesothelioma/Malignant Pleural Effusion.

San Marino, California, Us

Bethesda, Md, Us

Menlo Park, Ca, Us

Regulatory Reporting of Phase 4 IND studiesManaged Controlled Procedural Documentation (CPD) routing and annual review responsibilities for several global regions. Consolidated learnings and new requirements into new and existing CPDs for Phase 4 and Investigator Initiated Trials. Collaborated with functional groups to define efficient communication processes. Planned SOP updates based on upcoming system changes and annual development plan.

Responsible for eCRF, RTSM, and ePRO system setup and management.Subject Matter Expert for the IRT design and development process. Managed and advised teams on best practices for the use of EDC, eCOA, and IVR systems. Provided leadership, support, and influence to ensure the timely delivery of high-quality systems and tools. 100% on-time system go-live for 50+ study-specific systems. Supervised multiple clinical data management personnel and vendor PM teams. Responsible for program-level relationships with vendors and ongoing vendor assessments, including bug/issue tracking and corrective action implementation. Managed vendor contracting, budget forecasting, and invoice payments. Led SOP development and standardization of IVR-related job aids and templates. Led as the user representative and DMP liaison for the design of a core RTSM system. Led the review of validation documentation.

Led multi-function group on project for vendor selection, design, and validation of Allergan core IVR System. Acted as Subject Matter expert for IVRS development. Managed EDC and IVR system design/configuration, validation, and study team training. Participated in process definition and SOP development efforts with regard to EDC design/development, IVRS setup and conduct, and subject transfer process. Advised and mentored study teams on their roles and responsibilities with respect to the setup process and use of EDC, ePRO, IVRS. Advocated and educated clinical teams on use of electronic systems. Managed vendor contracting, study configuration testing and study team training.

Contributed to protocol design and execution for several global phase III studies in urological indication.Subject matter expert in urodynamics tracing quality reviews and training. Assisted in timeline and document management of IVRS, electronic diary, and graphics vendors. Participated in committee to implement new CTMS (IMPACT); Led Report development sub team. Budgeted and projected payments for sites, consultants, and multiple vendors

Raleigh, North Carolina, Us

Supported multiple Oncology, Neurology, and investigator-initiated clinical studies.