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Data Entry Project Manager

Location:
San Jose, CA
Posted:
April 21, 2023

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SUMMARY OF QUALIFICATIONS

As a seasoned strategy and management consultant with over 15 years of experience in the healthcare industry, I have a deep understanding of healthcare informatics, project management, and the pharma/life sciences, medical device, provider, and payer landscape. My expertise lies in IT-SaaS (EMR, Drug Safety/PV, ERP, CRM)/digital transformation, compliance, regulatory, strategy, and operations. I have a proven track record of driving successful projects, optimizing operations, and achieving strategic goals for my clients. With my comprehensive industry knowledge and innovative problem-solving skills, I am equipped to lead organizations through complex challenges and help them reach their full potential.

With a proven track record of successfully leading clinical information systems implementations and supporting digital transformation efforts for my clients across the globe, in the US, UK, Canada, and China, I have consistently delivered successful projects, streamlined operations, and helped my clients achieve their strategic goals. Leveraging my extensive industry knowledge, I am well-equipped to guide organizations through intricate challenges and empower benefit realization. I have a strong understanding of various project management methodologies such as Agile, Lean, Waterfall, Six Sigma, and KanBan. Additionally, I am well-versed in drug safety and pharmacovigilance processes, as well as validation & verifications standards per regulatory mandates (i.e., FDA’s21 CFR Part 11, EU Annex 11, GxP, HIPAA, GDPR, including GAMP principles). As a PMI-certified Project Management Professional (PMI-PMP), ICAgile certified-Agile Coach (ICP-ACC), Six Sigma Green Belt, PROSCI-certified Integrating Agile & Change Management Professional, and Certified Scrum Master (CSM) with dual degrees in Nursing (BSN) and Computer Systems Administration, I am currently pursuing a Data Science Masters’ Program

In addition to my extensive expertise in healthcare informatics, project management, and the life science - pharmaceuticals & medical devices, provider, and payer landscape, I am also involved in the sales pursuit process. From exploration to building and cultivating relationships, driving consensus, continuously qualifying clients and adapting to their changing needs, and motivating outcomes through tried and tested team expertise and experience as well as data-driven approaches and solutions, I am well-equipped to support organizations throughout the sales process. With my comprehensive industry knowledge and innovative problem-solving skills, I am able to deliver successful sales outcomes and support my clients in achieving their strategic goals.

PROFESSIONAL EXPERIENCE

Grant Thornton LLP 03/2020 – 07/2022

Manager, Advisory Transformation, Agile & Program Leadership Life Sciences Health Care

Led and partnered on multiple client projects across various industries - pharmaceuticals and medical device client specific

As a Project Manager for an ERP (Oracle) Upgrade and Migration Strategy for a pharma life science engagement; aided in the development of system requirements and specifications, and coached implementation teams in proper execution of validation documents. Managed CSV process and ensured appropriate validation of cGMP computer systems.

Led M&A IT Risk & Controls Program for a publicly traded aerospace manufacturing company, coordinated internal and external audits, and provided auditing and controls expertise to IT.

Managed projects/programs for an international non-profit home health care provider, and oversaw customer relationships, and delivered highly effective program management.

Established future state framework for implementing a quality department/organization and its integration into its current network enterprise for biotech company.

Contributed to internal firm activities and collaborated on various strategic projects.

Designed solution offering amid Covid-19 for telehealth/telemedicine, patient & clinician engagement strategies, pop health, remote workforce enablement, application rationalization, and the evolving digital technology landscape.

Partnered in the development of various Telehealth Growth Strategies Development POV collateral. Co-led the development of the new associate experience in the Advisory Practice and contributed to diversity, equity, and inclusion through active involvement with the internal Business Resource Groups.

Served as a member and co-moderator of the AI Topic Team for the Life Sciences/Pharma Practice, attended focus groups on intelligent automation and AI related initiatives in Life Sciences specifically Regulatory.

iRhythm Technologies, Inc. 05/2019 – 11/2019

Senior Technical Project Manager (TPM)

Led numerous project engagements from pre-sale to post-implementation for iRT’s medical device, Zio patches and software solution integration

Led project teams to identify opportunities for productivity improvement and design and implement solutions that drive sustainable results for clients.

Worked with the sales team to qualify leads, determine needs, and recommend solutions.

Collaborated with IT, security, and clinical champions to ensure solution integration of the medical device solution (Zionoatch and EHR) into the client's workflow and security requirements.

Managed the pre-sales process, sales funnel, and all paperwork (contracts and risk assessments), ensuring timely completion.

Led project management for EHR Integration implementations, including scoping HL7 specifications, project and technical resource coordination, project tracking, and communication.

Ensured timely completion of all technical components, both at our customer and our testing, and subsequent release into production.

Leveraged technical project management skills to build comprehensive plans, identify risks, and ensure a smooth process.

Actively assisted cross-functional teams in defining and managing project milestones.

Ensured transparency and visibility to stakeholders on project progress and quality through regular status updates and metrics. Liaised between tech operations, CX, sales, support, and DevOps over customer issues, managing expectations and issue resolution

GE Healthcare Partners 04/2017 – 10/2018

Senior Consultant, Global Productivity Solutions

Provided strategic and operational consulting services to healthcare organizations globally.

Led project teams to identify opportunities for productivity improvement and design and implement solutions that drive sustainable results for healthcare provider, payer, life sciences - medical device and pharmaceuticals clients.

Worked with cross functional teams to develop business cases, project plans, and implementation strategies to deliver measurable value for clients.

Conducted assessments and analyses to identify opportunities for improvement and provide recommendations.

Collaborated with stakeholders to develop / implement process improvements, organizational redesigns, and technology-enabled solutions.

Provided subject matter expertise in areas such as operational efficiency, supply chain optimization, revenue cycle management, and clinical process redesign.

Developed and maintain relationships with clients and act as a trusted advisor to senior leaders.

Managed project budgets, resources, and timelines to ensure successful project delivery.

Developed and delivered presentations and reports to clients and internal stakeholders to communicate project progress and recommendations.

Stanford Health Care 03/2014 – 04/2017

Senior IT Project Manager

Held two important roles, serving as Senior (IT) Project Manager for IT Services & Int’l. Medical Services

For IT Services:

Oversaw and managed projects and programs for two departments, International Medical Services and Digital Health.

Collaborated with clinical and business department leaders to direct mid to large-scale programs with multiple sub-projects.

Led the planning, implementation, and maintenance of software solutions, including SaaS/Hybrid cloud environments, workflow optimization, change management, and issue resolution for clinical and non-clinical applications as well as corresponding medical devices with biomedical services..

Among my projects were the implementation of Epic Willow IMS for Pharmacy Supply Chain, Swisslog Robot Implementation, and the 500P New Stanford Hospital Project-PathToActivation.

For International Medical Services:

Collaborated with senior staff and leadership to develop and implement strategies for the operations of Stanford International Medical Services, supporting international patient services, consulting, care delivery, and business development.

Coordinated implementation strategies across Stanford Health Care, Lucille Packard Children's Hospital, and other medical centers.

Assisted in the development of department SOPs and infrastructure to support external delivery of overseas offices and program planning for education and consulting services delivery.

Among my successful projects were the IMS Data Strategy Project, Cost Estimate Automation for International Patients, and the Global Business Development Projects.

Led and partnered with teams on initiatives such as the International Telemedicine/Telehealth Project, Stanford Healthcare Navigation, and IMS Corporate Partners Program (CPP) Collaboration Project.

PricewaterhouseCoopers LLP 01/2011 – 01/2014

Manager, Health Industries Advisory, Healthcare IT and Provider Enterprise Transformation (HITPET)

As a Manager in Healthcare IT and Provider Enterprise Transformation (HITPET), I have successfully led and partnered on a range of client projects, including:

Quality Program Development for a leading pharmacy benefit management, established a future state framework for implementing a quality organization and department, developed metrics to measure quality and implementation of controls, and analyzed and redesigned work plans and process flow.

Care Management Model Development for the largest health insurance provider in Texas, collaborated in developing a Decentralized and Longitudinal Care Management Model. Developed the roadmap for both Care Models, and created training plans, hiring plans, job aids, and criteria for outcome measurement.

Led an engagement as the Project Manager for a Pharmacy Benefit Management (PBM) - acquired by a Fortune 500 managed care company, supported day-to-day clinical pharmacy operations; developed and responded to state-mandated and commercial reporting requirements; and developed an interdepartmental project and issue tracking dashboard for executive leadership’s review.

RFP Management for a new hospital for a faith-based health system in the west coast, assisted with opportunity identification, proposal strategy development, and proposal debrief and response with internal and project/client leadership.

ICD-10 Assessment and Implementation for an independent, non-profit, community-based healthcare organization in west coast and a southeastern state academic university medical center, led client and vendor readiness assessment, provided gap analysis and impact report, and developed a detailed plan during the various testing phases.

Clinical Content Development for a southeastern teaching hospital, assisted in the organization and prioritization of clinical content, developed electronic order components, and defined the requirements for the development of education and training programs.

NTT Data Consulting (formerly Dell Services) 12/2008 – 01/2011

Sr. Principal, Business Consulting, Healthcare Services

As a Sr. Principal, Business Consulting for Healthcare Services was involved in local and international projects.

Spearheaded a transformative HITECH readiness assessment and enterprise-wide EMR implementation for a faith-based health system in the west and seamlessly integrated clinical information systems and paved the way for Meaningful Use compliance.

Led the charge in developing standardized clinical content for Tenet Healthcare Corp, promoting collaboration, and driving consensus among executives, clinicians, and business stakeholders, and establishing a steady cadence for effective communication and training.

Pioneered the implementation of an Electronic Multi-Disciplinary Documentation (EMD) program for XiangYa No.2 Hospital in ChangSha, Hunan, China, harnessing cutting-edge technology to revolutionize healthcare delivery in the region.

Provided invaluable support in developing the clinical informatics program for a 47-member hospital health system, lent expertise in clinical process improvement, electronic medical record (EMR) implementation, CPOE, governance, and organizational change management, driving the organization towards greater efficiency and success.

Deloitte Consulting LLP 12/2007 – 12/2008

Strategy & Operations Senior Consultant/Specialist, Life Sciences Healthcare (LSHC)

Led and partnered for the following representative list of client project engagement.

Epic OpTime Gap Analysis east coast faith-based health system network as Project Coordinator, documented the current-future state mapping from both the business and clinical operation workflows, which also included Pharmacy and Supply Chain for Epic OpTime surgery module implementation. Partnered with Pharmacy, Materials Management and Supply Chain to capture end-to-end process. Provided re-design recommendations and solutions for the issues and gaps identified with specific focus on BSHSI’s regulatory design reviews and clinical quality initiatives.

EHR Vendor Selection faith=based academic medical center in the Midwest, Lead PMO Coordinator, engaged project team support, leadership engagement, and training development and delivery, communication support, and other business development activities and other firm initiatives.

BearingPoint (formerly KPMG LLP) 12/2005 – 12/2007

Senior Consultant, Public Services, Global Healthcare

In my role as a Senior Consultant for BearingPoint's global healthcare and public services practice, I've been engaged in multiple healthcare projects, where I've led and partnered in the following representative list of client project engagements.

Served as the Epic ClinDoc Certified Lead for Guthrie Health System, leading the assessment and audit of built order sets, validating functionality in Epic, and reviewing and validating regulatory design and mandated KPIs for the Epic In-Patient Clinical Documentation Build Audit.

Acted as Team Lead for Clinical Content Development at BT Health and London NHS Trusts, for the UK NHS Connecting for Health (London Cluster), R1-R2 Release, Cerner Millennium Solution. I led and assisted in acute care clinical process evaluation efforts, including process mapping, functional gap analysis, and organizational readiness at multiple acute care trusts in the United Kingdom in preparation for an electronic medical record deployment by the National Health Service. I also evaluated the London (United Kingdom) local service provider program, reviewed deployment resource plans and approach, and identified opportunities for overall organization realignment, enhancement, and deployment acceleration.

Lead Project Coordinator for Vendor Selection at Creighton University Medical Center. I prepared the EMR/HER vendor selection process, evaluated vendor strengths based on defined and prepared high-level requirements, and prepared and collated vendor scorecard and checklist. I narrowed vendor finalists and presented fit with the organization. I also coordinated vendor and stakeholder roadshow meetings and presented the client's final scoring and provided strategic recommendations based on initial client requirements.

Served as an Epic Clinical Documentation Sr. Consultant for Clinical Content Development for Epic EMR at Sutter Health. I collaborated heavily with the client, vendor, and third-party stakeholders. I was involved in build, coded nomenclature, evidence-based medicine, and standardization of care principles, while collaborating on vetted clinical workflow, process redesign, clinical content strategy, training development and delivery, and project engagement communication.

NTT Data Services (formerly Dell Services/Perot Systems) 04/2005 – 12/2005

Senior Analyst, Clinical Applications

Engaged in a healthcare project as an on-site consultant for Stanford Hospital & Clinics (SHC)

Assisted clients implement clinical information systems; support clinical transformation efforts; support aspects of system development life cycle including design, build, testing, training, deployment, and post live support activities.

Participated in and/or lead clinical redesign efforts as appropriate.

Served as a member of implementation team consists of client personnel, software vendor associates, as well as other consultants.

Worked with client personnel to define functional and technical system requirements as appropriate. Facilitate design sessions and/or issue resolution sessions as necessary to accomplish the project objectives.

Performed hands-on application build activities as necessary. Facilitated application testing (i.e., using test scripts).

Developed training materials and/or system documentation.

Participated in system deployment activities, which may necessitate weekend and/or off-hour support.

Provided positive support and knowledge transfer to the client’s long-term operational support personnel.

Johnson & Johnson (J&J) 05/2002 – 04/2005

Drug Safety Associate, Global Drug Safety Surveillance & Pharmacovigilance, Janssen R&D (formerly J&J PRD LLC)

At Johnson & Johnson, I held two important roles, serving as a Drug Safety Associate for Janssen R&D and as a Technical Service Specialist, Healthcare Informatics for LifeScan, Inc.

As Drug Safety Associate, Global Drug Safety Surveillance & Pharmacovigilance, Janssen R&D (formerly J&J PRD LLC – a J&J Company)

Collected and documented routine serious adverse event reports from clinical trials and post-marketing spontaneous reports, ensuring compliance with company SOPs and regulatory requirements.

Triaged reports for regulatory reporting purposes and facilitated communication within cross-functional departments.

Prepared clinical narrative summaries and coded all adverse events, indications for use, and concomitant medical conditions.

Evaluated case files and prepared proper forms for reporting to regulatory agencies, ensuring completeness and clarity.

Initiated and coded cases in the safety database and performed basic searches for data queries.

Helped in the preparation of expedited reports to regulatory agencies and partner companies, including 15-day Alert reports, IND Safety Reports, and Serious, Labeled Expedited Reports

Participated in discussions with requesting clinicians and consumers about drug safety information.

Reviewed data entry of peer reports to ensure quality entry and proper output for aggregate reports.

As Healthcare Informatics Technical Services Specialist, Lead, Professional Services Group (PSG), LifeScan, Inc. - a J&J Company)

Supplied rapid, accurate, knowledgeable, and professional technical support for all Health Care Professionals, Data Management, Field Sales, leading to remarkably high customer satisfaction and retention.

Provided effective customer issue resolution based on prepared potential MDR information and potential liability situations, accurate information retrieval for potential medical cases, and accurate complaints verification that meet the reporting requirement for medical devices.

Maintained and analyzed the medical device report complaint history and supplied information for special requests and legal issues.

Demonstrated a strong understanding of FDA, Federal & State regulatory requirements for medical device manufacturers, hospitals, and other medical facilities.

Ensured compliance with requirements for hospital and lab accreditation through such agencies as CLIA, JCAHO, and CAP

Demonstrated an understanding of reagent chemistry, clinical performance of blood glucose testing, and diabetes physiology and management.

Applied informatics knowledge and modules for connectivity software, hardware, and other computer peripherals, including firmware upgrades.

Managed regulatory letters, product inserts (PI), 510K letters, and literature, and supplied technical support to healthcare facilities.

HEALTH INDUSTRY APPLICATION EXPERIENCE

Business Productivity Applications

Microsoft: 365/Office - Word, Excel, PowerPoint, Visio, and Project

Google - Docs, Sheets, Slides, Hangouts, Drive, and Sites.

iOS - Pages, Numbers, and Keynote

Project Management: MS Project, Smartsheet, Trello, Asana, Slack, Atlassian Jira

Collaboration: Atlassian Confluence; Teams, Zoom, SharePoint, BOX, Dropbox, Drive

Business Productivity: OneNote, OneDrive, Notion, Adobe, Figma

Dashboards & BI: SAP BO WebI, Tableau, QlikView, MS PowerBI, GE Wall of Analytics

Reporting: Epic Edge Reporting, Radar, Epic Reporting Workbench,

PPM: Service-Now, Planview Daptiv

Provider & Payer

Inpatient/Ambulatory: Epic (ClinDoc, Order Entry, and e-Prescribing), Cerner (PowerChart, PowerPlans, and Orders Mgmt), QuadraMed Computerized Patient Record Soarian Clinicals, McKesson Horizon, and AllScripts (Sunrise Clinical)

Emergency: Epic ASAP, Cerner FirstNet, ED PulseCheck, CareFX Fusion

Peri-op & Perinatal: Epic OpTime/Anesthesia, Epic Cupid, Surgical Information System PeriOp, and CliniComp Essentris

Pharmacy: Epic Willow Inpatient/Ambulatory, Cerner PharmNet, Swisslog Robot, and Pyxis

RIS/PACS: DICOM, LifeIMAGE, Epic Radiant, GE Centricity PACS, Cerner RadNet

Ancillary: Macro Helix and Medtronic Paceart

Billing: Epic Resolute HB/PB, and Cerner RevCycle

ADT Registration: Epic Grand Central (Prelude/ADT) Scheduling & Patient Tracking Epic Cadence, Siemens Soarian Scheduling, Teletracking Transport & Bed Tracking

Clinical Content: Zynx Health and eClinicalWorks

Integration Engine Tools: Mirth (NextGen) Connect, Note++

Life Sciences (Pharma/Med Dev):

Compliance Risk Management

Safety, Quality & Regulatory Compliance – Regulatory Intelligence

HIPAA, GDPR; GxP (GCP, GVP, GMP, GLP; cGMP)

Veeva Pharma Platform

Other experience include:

ICH (E2F DSUR & PSUR Guidelines): EDC; CTMS (eTMF, IRT, EDC, SSU)

Data Analytics: Clinical Data Warehouse, Data Mart, Data Lakes

eQMS (Quality Management Systems - P&P; Training Documentation, Audit Trail,

MasterControl - Computer Systems Validation (CSV) / Annex 11, Versioning, V&V, Software Validation Assurance, SaaMD

EDUCATION

Data Science Masters’ Program Q4 ‘23

SimpliLearn (co-dev by IBM Watson Health), Distance Learning

BSc in Comp Sys Administration Dec ’00

Masters’ Inst of Tech San Jose, CA

Bachelor of Science (BSc) in Nursing Mar ‘94

Cebu Doctors’ University Metro Cebu, Philippines

Artificial Intelligence: Implications for Bus Strategy Aug ‘19

MIT Sloan School of Mgmt/Comp Sci AI Lab (CSAIL), Cambridge, MA

Agile and Scrum: Dramatically Improving SW Delivery Nov ‘18

General Assembly, San Francisco, CA

Critical Course RN Program 1994

De Anza College Cupertino, CA

LICENSES & CERTIFICATIONS

PROSCI Change Management Certified (CM), PROSCI, 2022

Agile Coach Certified (ICP-ACC), Sept 2020

ICAgile Professional (ICP), ICAgile, Aug 2020

PMI – PMP - Project Management Professional, PMI 2005

P3M – Project Program & Portfolio Mgmt, Dell, Jan 2009

Six Sigma Green Belt, Perot Systems Corp., Mar 2009

SFDC Admin & Development, Salesforce, Jan 20113

SAP BO Web Intelligence, Stanford, Oct 2014

SAP BO Advance Reporting w/ WebI, Stanford, Oct 2014

CCRN, CCRN Program Certification, De Anza College, 1994

RN License, Philippine Regulatory Comm – Sept 1994

Epic IP ClinDoc, EpicCare, Epic Apr 2006

EpicCare AMB Credentialed Trainer, Epic - Sept 2007

PUBLICATIONS

Determinants: Successful COVID-19 Vaccine Rollout, Grant Thornton

Creating & Sustaining a Winning Governance Model for Successful Transformation, Dell Consulting Services

A New Model for Healthcare Transformation, Dell Consulting Services



Contact this candidate