Brian Olender Email & Phone Number

San Jose, Ca, Us

South San Francisco, California, Us

Hellerup, Capital Region Of Denmark, Dk

Led development of internal CDM capabilities, infrastructure, and operations. Built out and grew CDM organization from six to 25 FTE employees. Performed gap analysis of existing trial operations and systems to determine CDM operational and infrastructural needs. Implemented data standards, including eCRFs, preferred EDC vendor, standard data output and analytics, and standard integrations between CDM systems and other system tools, including IRT, CTMS, and safety. Collaborated closely with IT to ensure proper system implementation, deployment, validation, and ongoing management.

South San Francisco, Ca, Us

Led development of internal CDM capability, infrastructure, and operations. Performed gap analysis of existing trial operations and systems to determine CDM operational and infrastructural needs and modifications to existing trial operations.

South San Francisco, Ca, Us

Led development of internal CDM capability, infrastructure, and operations. Performed gap analysis of existing trial operations and systems to determine CDM operational and infrastructural needs and modifications to existing trial operations.

South San Francisco, Ca, Us

Foster City, Ca, Us

Built EDC programming group from ground up, as well as managed day-to-day operations and internal staff of EDC programming group in Foster City and Seattle. Aligned entire group to standard operating procedures and processes. Led and participated in biometrics standards committee. Maintained and enforced use of global library for creation of eCRFs, edit checks, reports, and SAS Data Exports.

Abbott Park, Illinois, Us

Sr. Manager of Clinical Systems groupManaged implementation, project management, program management, and support of all systems and software in use by medical safety, biostatistics, clinical quality, and clinical science. Oversaw team of business analysts and project managers who delivered clinical systems to support research initiatives. Assessed and evaluated software vendors and other solution providers to help determine whether products and services meet business needs and adhere to regulations and best practices. Liaised between clinical research, clinical systems, and clinical IT groups to ensure systems were built and deployed according to requirements.

Abbott Park, Illinois, Us

Manager of Clinical Data Management groupOversaw daily operations of clinical data management group, including trial design and development, CDM operations (data review and cleaning), and assessment of new technologies, processes, and operational modalities. Created and executed organizational and operational policies that affected groups and processes by utilizing technical and professional skills. Coordinated and led efforts regarding work processes or operational plans and schedules to achieve department objectives. Built staffing plan by identifying resource requirements, writing justifications, obtaining approval, and coordinating selection process.

Abbott Park, Illinois, Us

Group Leader of Clinical Data Architecture (Clinical Programming) group. Company was acquired and changed from Guidant Corp. to Abbott VascularManaged clinical trial architects to build and develop trials in EDC according to protocols and business requirements. Monitored daily operations and provided direction to staff to achieve unit or project goals. Developed, created, and executed policies and procedures that affected work processes and personnel. Helped implement staffing plan by writing justifications for personnel, obtaining approval, and coordinating selection process with human resources. Interacted with internal and external customers during meetings, responded to requests, and explained procedures. Contributed to budget development and monitoring.

Abbott Park, Illinois, Us

Managed EDC development and deployment, including electronic Case Report Forms (eCRFs) and edited specifications using PhaseForward’s InForm product for use on drug eluting stent trials. Participated in protocol reviews, statistical analysis plans, and other clinical documents. Coordinated clinical data management activities by liaising with clinical scientists, clinical research associates, system analysts, QC analysts, clinical safety associates, and information standards librarian. Partnered with outside vendors, such as angiographic and IVUS central laboratories, to ensure that related eCRF design met vendor’s scientific and clinical requirements.

San Jose, Ca, Us

Planned, managed, and administered personnel, overall policies, and clinical systems group and task force goals. Analyzed department needs and established priorities, feasibility studies, and implementation plans for new or modified clinical systems or services to meet corporate goals and business development requirements. Liaised with decision makers in executive management, IM management, and other departments to identify and recommend clinical system methodologies and strategic plans. Identified potential vendor partners and maintained relationships and favorable contacts with current and potential vendor, client, and contractor accounts.

San Jose, Ca, Us

Managed implementation and validation of Oracle clinical database management system (CDMS) with remote data capture (RDC) component, Oracle Thesaurus Management System (TMS), Oracle adverse event reporting system (AERS), and statistical analysis software (SAS) system, including all budgets, timelines, system analysis, milestones, project goals, and documentation. Authored and reviewed validation protocols, SOPs, and regulatory documents. Collaborated with QA, QC, and validation departments to review and approve these documents in support of clinical system projects.

Gaithersburg, Maryland, Us

MedImmune Vaccines - Originally AvironManaged implementation and validation of Oracle clinical data management system, ARISg pharmacovigilance data management system, and Fraser-Williams IMPACT clinical trial management system. Authored and reviewed validation protocols, SOPs, and regulatory documents. Collaborated with QA, QC, and validation departments to review and approve these documents. Partnered with pharmacovigilance, clinical development, data management, biostatistics, and validation departments to deliver clinical systems that met all business needs and applicable regulations and policies.

Switzerland 🇨🇭 , Ch

Partnered with other members of RDE team to sell technology to clinical development project teams. Managed setup and implementation of EDC system for use in phase II and III clinical studies, including timelines, milestones, project goals, and documentation. Assembled and chaired large, international, interdepartmental task force. Corresponded with multi-functional groups to determine and assist with change implementation in EDC system in production and developmental environments. Contributed to and reviewed development of CRFs, validation procedures, eCRFs, SOPs, and regulatory documents. Developed curriculum and training on use of EDC system.

Menlo Park, Ca, Us

Morgan Hill, California, Us

Morgan Hill, California, Us

Bachelor Of Arts (B.A.), History

Physical And Biological Anthropology