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Work Background
Nagel's BagelsFounder and Owner Operator
Sep. 2022United StatesBuildout of a new location supporting the acquisition of systems, construction and personnel. This was a new venture starting a series of restaurant infrastructures potentially with multiple locations to manage and operate. All operations of the restaurant chain were under my purview. Directing 4 other business leads we developed a plan to build out a location and open the first of many restaurants. Responsible for placing qualified personnel into operations from sourcing, interviewing, presenting and closing candidates. Used social media to manage applications and searches on various job boards. The financials and timeline were my major focus for more than a year to stabilize the business and distribution accounts. I have been working to plan equipment acquisition and delivery with trained personnel as needed. An ongoing procedural library was established to establish the regulatory requirements of the regulatory agencies such as the Health Department and the Department of Agriculture.
OracleSr. Project Manager (Program Manager)
Nov. 2016 - Sep. 2022Atlanta, Georgia, United StatesOversaw the strategic direction alongside the sales team and executive management for Oracle’s Health Services Operations account management from a program perspective. Reviewed partnership relationships and managed governance programs to communicate major goals and milestones. Initial Point of Contact for the company's major clients and mid-level clients assigned to the Global Business Unit in Health Services Operations. Managed to the KPIs in place to monitor success, collaborating across departments to support committee meetings internally and externally with all levels of the organization. Key Contributions: • Acted as a senior-level liaison for customers, delivering report summaries, milestones, and contract deliverables, focusing on quality, timeline, and financials of the contract.
• Directed the IT Program Management tasks within the Oracle Platform so the customers’ clinical trials are collected and stored as expected.
• Single point of contact for the kick off of client happiness. Looking at trends and product enhancement requests for future versions to include customer feedback. P&L management within several contract engagements to optimize the performance, costs and timelines involved.
• Collaborated with cross-functional groups to communicate continuous improvement initiatives back to the customers and ensure development standards are being enforced based on customer review and UAT.
• planned and implemented migrations and upgrades of Oracles InForm product for multiple projects and multiple customers depending on the latest version readiness and customer availability to test.
Q² SolutionsSr Clinical Data Lab Analyst
Apr. 2014 - Nov. 2016Marietta, Georgia, United StatesEnsured quality control of clinical trial lab data collected from customer locations, shipped to testing labs, and transcribed into the collection system. Oversaw customer lab data operations management and submission for FDA review in relation to specific clinical trials. Key Responsibilities: Internally reported and summarized data review for project advancement to the final audit phase. Provided senior management with reporting and presentations on data, timelines, and customer feedback for contracted deliverables.
US Data Management EnterprisesProgram Manager
Aug. 2013 - Jan. 2014Cartersville, Georgia, United StatesOversaw Life Sciences projects, focusing on systems validation, resource and process modeling for clinical systems, and operations compliance. Understanding of business development in various departments within a pharmaceutical company to assist in evaluating the contract or continuing business of the customer. Business Consulting practices assisting customers by overseeing the managed projects within Healthcare and Life Sciences organizations providing program guidance. Key Contributions: Successfully delivered contracted deliverables, building relationships through effective people management and communication skills.
Liaison TechnologiesSr. Consultant (Clinical PM)
Mar. 2010 - Aug. 2013HomebasedImplemented Clinical Data Management Plans, coordinated internal teams and projects, and documented user acceptance testing for databases aligned with client expectations. Guided client implementation of EDC software in Oracle Inform, demonstrating strong data and project management skills. Collaborated with cross-functional groups to find solutions for client business needs, engaging in brainstorming, troubleshooting, and change solution management for contracted services. Key Contributions: Provided CDISC/SDTM support and guidance for SDTM Mapping within the CDM group, including eCRF building. Reviewed specifications with the Global Clinical Data Standards group and other Therapeutic Areas in the Inform EDC. Collaborated on external data submissions and ensured compliance for FDA drug approval through SDTM data submission. Managed timelines and workflows for 3 SDTM mappers, overseeing approved project plans and addressing offshore requests and testing cycles. (Senior Business Analyst - 50% FTE Consultant) Positioned to lead a team of SDTM Mappers and Integration Analysts, offering training and professional services to Merck resources in the CDM group. Developed self-sufficiency in Contivo software resources. Created and delivered the SDTM Knowledge Transfer (KT) program for CDM, conducting sessions in New Jersey and Bangalore, India. The training included three two-week sessions, two in India and one in the US, followed by a one-week shadowing for the two classes in India.
BioPharm Sytems (Contracted to Medidata Solutions)Senior Project Analyst
Sep. 2006 - Mar. 2010HomebasedImplemented EDC software for multiple pharmaceutical companies, managing EDC requirements gathering, deliverable approval, and post-implementation Hypercare. Conducted validation for platform updates, change control, and process improvement, utilizing strong data and project management skills to guide EDC configuration and system updates. Key Contributions: Set up and validated Oracle suite applications for client protocols (TMS, AERS, RDC), documenting installations and testing. Hired by BioPharm Systems to provide EDC consulting services, building eCRFs for the Rave EDC system, creating schedules of visits, patient calendars, and study timelines. Applied federal guideline verbatim and techniques in building studies, with expertise in Study Data Tabulation Model (SDTM) and Clinical Data Interchange Standards Consortium (CDISC). Conducted Rave Core Configuration setup and implementation before study build.
SynteractClinical Data Manager
Mar. 2006 - Sep. 2006Carlsbad, California, United StatesReview of Clinical Trial data and identification of issues for query generation. Data coding of lab data, adverse events and concomitant medications. Using electronic data reconciliation processes through reporting and analysis within EDC systems of the various Pharmaceutical companies (Inform, ClinTrials, Rave, Data-fax, In-house systems). Identification of Clinical protocol deviations and communications to the CRA for confirmation and resolution. Cross team involvement for initiating Pharmaceutical contact and maintenance of projects. Resolve Queries from Investigational Clinical Sites for compliance to the Clinical Trial protocol. Temporary role for short term to assist in process and client engagement of clinical trials.
Ligand PharmaceuticalsClinical Data Manager
Jul. 2003 - Mar. 2006La Jolla Shores, California, United StatesReview of Clinical Trial data and identification of change control issues for query generation. Data coding of lab data as the Lab Data Administrator, adverse events and concomitant medications as the Coding Lead. Using an in-house scanning (Pre-EDC) and data entry (DOS System) confirmation into the Clinical Database. Reporting electronic data reconciliation and analysis for Management. Identification of Clinical protocol deviations and communications to the CRA for confirmation and resolution. Project related Lab data management. Coding specialist for lab normal range collection (AE/ Conmed coding). Paper trial management and scanning process transition into EDC systems. Oncology, Women’s Health, Respiratory
Parexel International (San Diego)Clinical Data Associate
Apr. 2002 - Jul. 2003San Diego, California, United StatesReview of clinical trial data and identification of issues for query generation. Data coding of lab data, adverse events and concomitant medications. Using an in-house scanning and data entry confirmation into the clinical database for further data cleansing and analysis. Reporting electronic data reconciliation and analysis for management. Identification of clinical protocol deviations and communications to the CRA for confirmation and resolution. Lead clinical data planning and systems development for clinical data management group. Manage process improvement of the collection of data and creation of database objects. Psoriasis, Skin therapy, Oncology, Crone’s.
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