Life Science Programs – Projects (Not all-inclusive)

TCWGlobal (Akebia - managing programs and projects as part of the I.T. Group)

Migration of a centralized network location to a cloud-based environment

This centralized network location served as a data repository for multiple business functions. This drive was used without any standards nor types of controls over the kinds of data, the retention of it, as well as a lack of security standards. This effort provided a single source for all identified data needs. Some critical benefits included cost optimization, reducing risks of data loss, providing enhanced knowledge management, enabling collaboration, productivity, and business continuity, and providing additional Cybersecurity benefits.

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Implementation of TraceLink's (SaaS) Product Track – Serialization Project

To remain compliant under the FDA DSCSA (Drug Supply Chain Security Act) that was initially enacted in 2013 outlining the steps to achieve interoperable electronic tracing of products, this act, until 2023, required products to be traceable at the lot level. The 2023 effort, with a 27 Nov timeline, will allow interoperable electronic tracing at the product level. The project was initiated to implement the additional compliance requirements in partnership with our supply-chain management vendor.

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Clinical Analysis Platform Migration

The project was migrating current SaS (Statistical Analysis Software) files from the existing cloud platform to an upgraded one with the same SaaS vendor. Responsible for overseeing all client-related tasks and cross-organizational activities with the vendor PM.

TCWGlobal (Akebia - managing projects as part of Business Clinical Group.)

Argus Safety D.B. migration

The project was started to identify a full-service C.R.O. to host a unified Argus database solution and provide high-quality case processing and P.V. support that is fit for purpose for the future state of DSPV. This was accomplished via migrating two safety databases to help harmonize processes between therapeutic programs to provide better control and visibility of safety data, e.g., for inspection/audit readiness. Timelines were critical due to the migration completion needed to align with a planned product launch.

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eTMF Implementation and Migrations

This included SaaS Vendor selection via a P.O.C. (Proof of Concept) of 6 legacy studies and implementation of the out of box solution. The post-implementation effort included hyper-care and operational oversight that had the development of a system and T.M.F. migration S.O.P.s, work instructions, and operational checklists, as well as the project management of multiple T.M.F. migrations from various C.R.O.s. (3000 to 1.5mm documents)

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Non-Clinical Archival and Storage.

As noted in G.L.P. section 58.51, space is required for archives and should be limited to authorized personnel only to be used for storing and retrieving all specimens, blocks, and slides from the completed study. Akebia needed to partner with a commercial archive vendor that was a GLP-compliant archive storage facility vendor meeting all defined requirements to ensure compliance with required regulations.

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Regulator Agency Inspection Readiness

Provide project management oversite for the T.M.F. thread, including project plans, status tracking and reporting to key stakeholders, development of chronological boards and storyboards, and review and approval workflow processes. Additional responsibilities included aiding in training development and presentations for collaboration room use and processes, support for the overall I.R. with other thread P.M.s, and mock audit support. Further assistance was provided to the Pharmacovigilance team in subsequent document creation, collaboration, and PM support during additional I.R. and mock audit preparation.

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Clinical Trial Data Program Management

This included multiple aspects, including developing a program hierarchy that highlighted critical activities, from ongoing and one-time activities that had a potential risk of getting the team the required action item for performing two Database locks for multiple clinical trials. Additional responsibilities include developing a SharePoint data demand release process based on requests for data and overseeing the clinical data review committee.

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Instant Technology (Shire - managing projects under an EH&S program)

EH&S Material Compliance

This was a program-level implementation of Gensuite's Product Compliance Center Package (SaaS) to collect the regulatory data from the suppliers and C.M.O.s to ensure compliance against global regulations; it needed to integrate the JDE/SAP BoM and Sales data to enable additional regulatory reporting and notifications to E.H.S. regulatory agencies globally. The effort included resources from the JDE / SAP integration teams and the SaaS Vendor (offshore and local) for development and testing efforts.

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Achilles

This project was started to provide data collection and communication, both internal and external, to support the creation of an Operational Contractor Environmental, Health & Safety Pre-Qualification and Vetting System (CEPVS) utilizing a SaaS-based system (Achilles). Included in the scope were all operational contractors performing work that may be hazardous in nature (I.E., Electrical, HVAC)

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Laboratory Systems Verification

This project was started to develop a process and potential systems to initiate periodic reviews for lab system computers. The overall effort included documented S.O.P.s needed to align on periodic verification of back-ups and restore processes.

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RCGIT / Abbott / AbbVie (combined all within the same organization)

Program Management

eClinical

Creation of the program governance structure managed status, risks, & financials.

As a result of a cross-functional (R.A., Medical Affairs, Pre-Clinical, Quality, etc.) assessment and workshop, a detailed multi-year clinical strategy and roadmap was created. As part of this strategy and roadmap, several foundational elements were identified that needed to be implemented before or in parallel with some of the initiatives identified. This program proposed implementing the foundational elements required to execute the cross-functional clinical strategy. Items implemented would allow the business to meet the most urgent and critical business needs, standardization of data and delivery standards (Cross-functional Data Governance standards), study Management Reporting Capabilities (Operational Data Store), CDISC compliance (Master Data Management and Meta Data Repository) and improved efficiency to enable better decisions faster (Expanded integration of source systems into the E.S.B.)

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Clinical Operations

The Clinical Operations overall portfolio was in place to support all aspects of AbbVie Clinical Trials.

eTMF Phase 0 - Phase 1

This initiative was broken down into two phases, with the first phase (phase 0) focusing on the selection process for a vendor to work with us to move from a hard copy manual-based Trial Master File (T.M.F.) to a more automated and electronically stored eTMF. The second phase (phase 1) was initially implementing Veeva eTMF through a conference room P.O.C. A full implementation and post-implementation turnover to Operational I.T. This effort required coordination with the eClinical strategy to ensure that this implementation aligned with those goals.

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Quantum (Financial Management)

Various functional areas manage budgets, demands, and headcount to support the Research and Development (R&D) clinical development portfolio according to the planned timelines. Key responsibilities of the groups include: (a) managing clinical budgets and demands, (b) managing clinical payments, (c) managing global resources, (d) managing and supporting clinical project planning, and (e) supporting the clinical planning group. These work areas leverage a broad base of internal and external applications to access critical data and conduct its full range of activities. The Quantum application was a centralized web-based environment that aggregates information to be shared globally for the clinical project planning process by efficiently creating, managing, & tracking the R&D study forecasts, budgets & payments, and managing global study resources. Releases were based on developed backlogs and sprint cycles.

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Clinical & RnD Operations SharePoint Collaboration

This program was a bucket of money used throughout the year for improvements to Research and Development SharePoint sites for trial reporting and pipeline status. Development of these sites was done via backlog development and sprint cycles.

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I.T. Internal Program

This program focused on internal projects that were not part of any particular business function or were more technical and would impact the overall Research and Development organization.

Separation

The primary responsibility in this program was the oversight of separation activities involving SharePoint Upgrades, salesforce.com initiatives, and Lotus notes to SharePoint conversions. These efforts were shared with RnD resources and C.O.E. (Center of Excellence) project and program managers. Additional funding coordination effort was required since some aspects of this program spend were via capital funding for the enhancement portions that needed to be separate from the total Separation activity.

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Laboratory Performance Improvement

This project addressed current performance, reliability, and data integrity issues while providing a long-term foundation, including a robust architectural schematic and a comprehensive monitoring approach to aid in the proactive identification and localization of future issues.

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RnD Network Segmentation

This was a program-based effort to protect the R&D labs from intentional or unintentional compromise of lab research data. The initial scope covered a limited number of Lake County Labs, with the primary focus on what was determined as the most critical need, which was an inventory approach to gathering laboratory assets.

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PharmaDocs

PharmaDocs was a non–validated, custom Documentum repository and Webtop front end created to serve as a non-quality document repository for Global R&D. This effort was the migration of these documents into a validated Q.M.S. (Quality Management System.

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CMDB Remediation

This project was initiated to address discrepancies in CMDB (Configuration Management Database) for CI business applications. The project corrected relationships between the R&D Business apps to Abbvie's Infrastructure Configuration Items (C.I.s). It also determined consistent naming conventions for C.I.s across the R&D portfolio and defined and verified each app's different role-based technical contact information. A defined role-based process was also identified to maintain CMDB's CI business application information.

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Salesforce Governance

This effort was put in place to create standards and a governance committee dealing with the development and demand for force.com applications; multiple types of products were defined as quick hits, SDLC development (longer-term), and citizen development. The outcome of this effort was an overall request, review, and prioritization of standards and structure.

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Project Management

L.M.S. (Learning Management System)

This initiative started working with specific T.A.s (Therapeutic Areas) to review requirements and work with vendors and internal team members to perform phase 0 for the potential implementation of an L.M.S. for the different functions. The initial T.A.s were HCV Virtual Academy, Oncology, Neuroscience, and Immunology. Based on these other initiatives, the team was also charged with looking at a Global L.M.S. approach and recommending that to Senior Management within the Global Medical Affairs organization.

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NoPro / InFunction

The objective of the NoPro system was to ensure compound/product/disease state non-promotional material created by various functions within Abbvie is scientific/medically accurate, truthful, not misleading, and free of claims and promotional messages. The Infunction portion of the system was used by certain functions within G.M.A. (Global Medical Affairs) for specific review points (I.E., Scientific accuracy.) Multiple initiatives around this application were completed within different sprint cycles during my tenure.

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C.S.M. Plan Process

The solution allowed the C.S.M. directors to create an annual plan per franchise (T.A.), which had initiatives added throughout the year; the plans had to be finalized and approved by the end of December of each year. This SharePoint application allowed the users to send the plans for review & approval and modify them by adding initiatives and changing plan initiatives details.

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CARS Enhancement

The project was focused on enhancements to the Clinical Application Request System (CARS). This project was broken down into different threads. One was part of the Abbott / Abbvie separation program and was tied to the migration of this application from Lotus Notes to SharePoint 2010, with the other focusing on identifying additional enhancements.

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IMPACT (CTMS) Replacement

This project was the Phase 0 review of the IMPACT system, which was Abbvie's current Clinical Trial Management System (CTMS) at the time. The project was divided into two parts, with the initial one being determining the best direction to take, which was to either upgrade the current system or find a replacement solution. The second was developing a long-range plan for a CTMS aligned with the eClinical program. Completing this project led to the determination to move away from a COTS CTMS system and align with a vendor to develop a customized salesforce.com system.

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Subject Deviation and Issues Enhancements

This project was created to resolve multiple issues with the initial implementation of a SharePoint system that was used to track deviations or issues with patients in clinical trials. The variation is documented by a Clinical Researcher (C.R.O./Monitor) and sent for review by the Study Designated Physician or Clinical Program Management. Remedial steps and impact were analyzed, and the information was sent back to the principal investigator site and C.R.O./Monitor for action (if required.) This project had to be completed within a narrow timeframe to ensure compliance with previous audit issues.

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Clinical Studies Monitoring Visit Report

The primary function of this project was to create a simplified data entry tool for the monitors to create visit reports after visiting clinical trial study sites. This was previously done through several different screens within the client's current CTMS (Clinical Trial Master System). The project was a shared effort with internal I.T. and an outside developer.

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Clinical Trails Data Entry Disclosure

This project was initiated to provide a single-entry point for the Clinical Registration group to enter the data needed to post to the Clinical Trials government website. Before this, the teams were required to enter data through three entry points.