Business systems analyst

SUMMARY OF EXPERIENCE:

Solutions Designer with extensive experience in the medical field in roles that include EMT, clinical, and project management for RTSM design and implementation. Highly effective at working with leading doctors in the industry, spanning several therapeutic areas in the clinical trials/pharmaceutical space. Adept at understanding the practical real-world application of the RTSM system, from an end-user perspective, giving an advantage to the success of system projects.

PROFESSIONAL EXPERIENCE:

PAREXEL international, Billerica, MA (Decentralized) (December 2017 - Present)

Solutions Designer

Provide platform agnostic consultation to clients on all aspects of system design as subject matter experts, working with internal departments (production, SPSS, etc.) and 3rd parties as necessary

Managed and led study design and changes to studies and prepared required documentation associated with this process, with input from the internal stakeholders as necessary

Provided leadership in developing requirements which included requirements elicitation, requirements analysis and negotiation, requirements validation, end to end UAT activities and requirements management

Created and configured projects within the appropriate toolset

Developed and maintained expertise in system design, PAREXEL Informatics RTSM services and industry trends

Supported pre and post sales activities, including product demos, RFP support, and client standards development

Promoted efficiency, quality and consistency in requirements design process

Communicated regularly with internal and external team members regarding study status and provides timely notification to all appropriate parties with deviations from timelines and/or deliverables

Actively identified, managed, and mitigated any project risks in a collaborative approach with other SMEs and the Project Manager, maintaining accurate documentation, and communicating to internal and external parties as appropriate

Understood financial implications of proposed solution and liaised with client and Project Manager as required

Attends face to face client meetings and investigator meetings as necessary (may require travel)

Ensured compliance with SOPS and other relevant regulatory body directives

Assisted with department strategies and goals, improving processes and procedures

Ensured management receives adequate and timely feedback on appropriate issues giving rise to concern

PAREXEL international, Billerica, MA (Decentralized) (September 2017 – December 2017)

Project Manager

Ensured delivery of RTSM Services and / or products to clients, within expected timelines and budget, with quality; including resource planning and management

Served as primary client contact for the study and manages the client relationship

Supported pre-sales process

Managed the project timeline regularly, sharing this information with internal stakeholders and the client as appropriate

Communicated regularly with internal and external team members regarding study status and provides timely notification to all appropriate parties with deviations from timelines and/or deliverables

Actively identified, managed, and mitigated any project risks, ensuring appropriate input from all stakeholders, maintaining accurate documentation, and communicating to internal and external parties as appropriate

Identified inefficiencies with current processes and recommends improvements

Managed client expectations effectively

Utilized delegation and negotiation skills with regards to project tasks, to obtain maximum productivity and team involvement

Facilitated training for clients as required

Attended face to face client meetings and investigator meetings as necessary (may require travel)

Successfully completed project deliverables including, but not limited to client signatures and user documentation

Ensured compliance with SOPSs and other relevant regulatory body directives

Resolved study issues in a timely, proactive and effective manner

Assisted with department strategies and goals, improving processes and procedures

Owned and drove project financial management, to include ensuring project profitability, contracting and invoicing progression and changing request management

Clarus Eye Centre, Lacey, WA (July 2016 – September 2017)

Ophthalmic Technician

Assessed new, existing, and post-op patients

Checking Visual acuity

Proficiency using slit lamp and tonometer to measure intraocular pressure

Manifest Refracting

Chief Angiographer; performing both Fluorescin and Indocyanine Green angiography

Performing HRT, OCT, GDX, visual fields, B-scans

Assisting with Procedures such as SLT, Focal

PRP laser photocoagulation, inter-vitreal injections including Lucentis, Avastin and Steroid

Cascade Eye and Skin, University Place, WA (December 2015 – July 2016)

Ophthalmic Technician/Retinal Angiographer

Assessing new, existing, and post-op patients

Checking Visual acuity

Proficiency using slit lamp and tonometer to measure intraocular pressure

Manifest Refracting

Chief Angiographer; performing both Fluorescin and Indocyanine Green angiography

Performing HRT, OCT, GDX, visual fields, B-scans

Assisting with Procedures such as SLT, Focal

PRP laser photocoagulation, inter-vitreal injections including Lucentis, Avastin and Steroid

Bartelson Transportation, Puyallup WA (May 2015 – August 2015)

Project Manager

Facilitated discussions and collected requirements from a group of non-technical users Documented written business and functional requirements. Developed and maintained project schedule, identified and tracked milestones and identified and managed cross-functional dependencies. Established requirements and managed change control throughout the development process. Improved an existing software application system, making it intuitive

Tested and trained the new application with the end users

Managed resources to devise/implement project-specific functionality Create Training Documents

Discussed intended system functionality with Project team

Determined timelines for system configuration relative to overall delivery

Built effective partnerships with other internal teams to ensure project completion though all phases of the development process

Attended daily scrum/check-in meetings and reports progress to the team Identify and report any areas of concerns related to timelines

Wrote all test cases for UAT (user-acceptance testing) Unit test throughout production life-cycle

Endpoint Clinical, Startup, San Francisco, CA (Feb 2012 – June 2014)

Design Project Manager

Worked primarily with Development/Programming Team and collaboratively with Project Manage resources to devise/implement project-specific functionality

System configurator of Interactive Response Technology (IRT)

Used endpoint proprietary system-design tool to configure IRT systems

Configured and unit test IVR (Phone) and IWR (Web) integrated systems for clinical trial application

Read, wrote and created queries with SQL

Pulled SQL queries

Configured and unit-test reports

Configured and unit-test alerts and message notifications.

Participated in study kick-off meetings (KOM) with internal study team to launch system development

Discussed intended system functionality with Project team

Determined timelines for system configuration relative to overall study delivery

Built effective partnerships with other internal teams to ensure project completion though all phases of the development process.

Attended daily scrum/check-in meetings and reported study configuration progress to the team

Identified and reported any areas of concerns to PM related to timelines

Acted as subject matter expert for IRT system design based on client clinical study protocol

Attended study clinical protocol review

Wrote all test cases for UAT (user-acceptance testing)

Unit tested throughout production life-cycle

Project Manager

Developed and maintained project schedule, identified and track milestones and identify and manage cross-functional dependencies

Conducted daily scrum/check-in meetings and reports study configuration progress to the team

Acted as primary point of contact for clients, keeping them apprised of all project developments while

maintaining stellar client satisfaction.

Built effective partnerships with other internal teams to move project through all phases of the development process

Developed and maintained project schedule, identified and track milestones and identified and managed cross-functional dependencies

Established baseline requirements and managed change control throughout the development process.

Acted as subject matter expert on client clinical study protocol and the transfer of study requirements into the endpoint PULSE platform.

Managed ongoing reporting of project health and profitability to internal and external stakeholders.

Wrote all test cases for UAT (user-acceptance testing)

Unit tested throughout production life-cycle

Conducted end- user training.

Diablo Valley Eye Medical Center, Retina Institute of Florida, Florida Vision Institute, East Florida Eye Institute (2004-2012)

Ophthalmic Technician/Retinal Angiographer/Clinical Research Coordinator

Assessed new, existing, and post-op patients

Checking visual acuity

Proficiency using slit lamp and tonometer to measure intraocular pressure

Skilled at Manifest Refracting

Served as Chief Angiographer; performing both Fluorescin and Indocyanine Green angiography

Performed HRT, OCT, GDX, visual fields, B-scans

Assisted with Procedures such as SLT, Focal

PRP laser photocoagulation, inter-vitreal injections including Lucentis, Avastin and Steroid

Clinical Research Coordinator

Provided oversight and management for human research studies

Demonstrate knowledge and proficiency of Good Clinical Practice (GCP). .

Delivered results to stakeholders.

Provided comprehensive planning, direction and leadership to the technical staff.

Ensured that adverse events are correctly reported and documented.

Checked the completeness and accuracy of the case reports.

Managed and coordinated proposal and contract needs to meet the clinics goals.

EDUCATION:

New Hampshire Technical Institute, Concord, NH

General Coursework taken

Riverside Community College, Riverside, CA 2002

General Coursework taken

University of New Hampshire, Durham, NH 2001

Coursework taken towards BS, Bio Science

MILITARY SERVICE:

1996-2000 Combat Medic, U.S. Army – National Registry EMT-B

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