Elaine Lowell Email & Phone Number

Tokyo, Jp

Tokyo, Jp

Cambridge, Massachusetts, Us

● Supporting COVID-19 research in collaboration with Operation Warp Speed o Develop and build CRF21:11 Data Repository for datasets, statistical programing and regulatory outputs for COVID-19 Phase 3 study; coordinate with infrastructure, CSV and Quality to ensure critical trial data remains available only to appropriate personnel● System Administrator for Clinical and Regulatory systems and applications including o SAS analytics o Veeva Vault RIM and eTMF o SaaS and desktop applications such as PleaseReview, Extedo, Cytel EAST, Rosetta Phoenix, Extedo, DocuSign

New York, Ny, Us

Tokyo, Jp

Lead the analysis of, and provide guidance on technology solutions in support of a new clinical GMP manufacturing facility for cell therapy and personalized medicine. Implementation of Blue Mountain for Regulatory Asset Management. Experience with Vineti for Chain of Identity/ Chain of Custody for Supply Chain Management for apheresate and cell therapy product. Implementing Blue Mountain Regulatory Asset Manager and Vaisala Continuous Monitoring System.

Cambridge, Ma, Us

Strategic IT liaison to Regulatory stakeholders including eTMF. Development of strategic roadmaps for system development. Works with the business to ensure the understanding of requirements and fit of the solution to the business process. Serves as super-user, trainer and provides technical and functional expertise during the selection, testing and implementation of applications.

• Enterprise-wide Implementation of SharePoint Online imitative and governance. SharePoint Designer, Trainer and Business Owner. Migration of document libraries, lists and development of collaboration spaces. • Information Governance Lead for Clinical Operations – development of clinical systems glossary for taxonomy, stewardship and security classification in alignment with corporate/industry standards. • Veeva Vault Clinical Business owner (CTMS) (eTMF). • Veeva Customer Community CTMS Early Adopter Representative • CFR21:11 Development lifecycle management requirements, validation, release and training

Tokyo, Jp, Jp

• Consulting Business owner Veeva eTMF • Migration and eArchiving projects for intellectual property post-acquisitions and mergers • Oversaw Project Managers, Consultants; Vendors, coordination with compliance

Durham, North Carolina, Us

● Commercial Development for Perceptive MyTrials Analytics and Trial Management Platform Products● Product Owner for enterprise-wide Documentum implementation● Implemented new business model and training for off-shore development team, Hyderabad, India● Agile and SAFe experience as Agile Coach, Certified Scrum Product Owner, Scrum Master, BA● Enterprise architecture and system integrations for analytics, resource and financial management● Consulting Analyst for Corporate Systems for financial and legal reporting and resource management

• Consulting Services for Life Science and Health Care organization for contract management; compliance and regulatory submissions• Researcher for Health Information Management Systems Society (HIMSS) Health IT Body of Knowledge resource Web site

Cambridge, Ma, Us

Business Lead for conversion of paper Trial Master File to electronic (eTMF) in PhlexEview utilizing TMF Reference Model as an industry standard.

Cambridge, Ma, Us

Analyzing and designing business processes, and building electronic systems for the management of records from Clinical Trial Research Projects at Biogen Idec.

Cranford, Nj, Us

• Merck Genomics knowledge management (SharePoint) and specimen repository management• Structured Authoring Quick Start Program for marketing department• Global eArchive Trainer for Astra-Zeneca Served as clinical SME and analyst to gather requirements• Electronic Trial Master File (eTMF) implementation utilizing TMF Reference Model

Marlborough, Ma, Us

● Lead Global Document Management (TMF/eTMF); Document Management Trainer; Inspection/Audits ● Supervised staff of 15 direct reports ● Due Diligence with Department of Justice; Inspections by Health Authorities ● Managed staff of 15 Clinical Research Associates and Coordinators; established Formal Mentoring program, resulting in 100% retention and 80%promotion of participants

Boston, Ma, Us

● Oversaw electronic and paper records department for drug development and regulatory affairs● Implemented GLP archive resulting in on-site GLP Laboratory ● Supported transition of paper to electronic health authority submission● Compliance activities included GLP, GCP inspections, SEC-mandated due diligence, legal discovery; ● Designed proprietary Oracle knowledge database

Basel, Baselstadt, Ch

Competitive Intelligence; Expert searching for medical safety; preparation of regulatory submission components.

Master Of Arts (M.A.), Corporate And Organizational Communication

Mls, Information And Library Studies

Ba, English

Healthcare Informatics And Management