Carl Thompson Email and Phone Number

RTSM Design Lead responsible and accountable for RTSM solutioning decisions focused on the development of RTSM systems to support Johnson & Johnson (J&J) clinical research efforts across various therapeutic areas (ie: Cross Therapeutic Areas or X-TAs). Therapeutic areas include, but are not limited to, the following: Cardiopulmonary, Communicable Diseases, Neuroscience, and Specialty Ophthalmology.Duties include: Serving as an RTSM liaison to Cross Therapeutic Area (X-TA) stakeholders, creating and maintaining healthy relationships that facilitate effective and successful RTSM system builds.Gathering J&J stakeholder requirements, making RTSM system design decisions, approving RTSM system specifications, and consulting on acceptance testing for new and ongoing trials in X-TAs.Creating, maintaining, and improving “RTSM System Design Best Practices” for X-TAs in alignment with RTSM standards and Core Business Practices, and applying these RTSM Design Best Practices in each new or enhanced X-TA RTSM system build.Meeting regularly with X-TA stakeholders to discuss/review Lessons Learned and to understand potential, emerging X-TA needs that may result in updates to the X-TA RTSM Design Best Practices for each X-TA RTSM system build.

Fully embedded within the Johnson & Johnson Innovative Medicine RTSM team (formerly known as Janssen RTSM team) as a PM who facilitates the implementation and maintenance of third party provided IWRS systems having a TA focus on early phase oncology studies.Duties include: • Provide IRT subject matter expertise to a cross-functional study team comprised of internal/external stakeholders.• Work closely with each of Janssen’s preferred IWRS providers to ensure IRT systems are available to support study needs throughout the lifecycle of the trial.• Lead all IWRS related activities (ie: RFP, requirement gathering, IRT spec development, UAT, system enhancements, study maintenance, and IRT closeout).• Support all IRT integrations (ie: EDC/RAVE, eCOA, Cquence, Optimizer, depots, etc).• Maintain an awareness of industry benchmarks to ensure Janssen RTSM processes are consistent with the industry’s best practices.

Providing project management, administration, and leadership to project teams in order to ensure that projects proceed on time and within budget. Providing clients with timely project status information and serving as the key operational interface between the client and Parexel's Medical Imaging group. Responsibilities include management of study specific documentation, planning and scheduling of activities and deliverables, resource planning, risk management and mitigation, financial tracking and control, client interaction, and team leadership. Preparing trial material, including appropriate guidelines and validation documents, ensuring compliance with FDA regulations and company-wide SOPs.

WebEZ is a web based IRT application that is offered to clinical trial Sponsors and CROs who are seeking alternative solutions to more traditional and much more costly IWRS/IVRS options. As a prebuilt IRT application, WebEZ will be configured based upon actual protocol specs, and the client's WebEZ application will be made active in a matter of days. Once active, both Client and Site users will have a fully functional IWRS system for their study that has the ability to perform all patient transactions, automated resupplies, and real-time study data analyses. PM Responsibilities include:Drive all cross-departmental activities that are necessary to support, develop, and refine the WebEZ service offering. This includes maintaining both business and technical WebEZ roadmaps while in collaboration with key Business Stakeholders from IT, Software Development, Project Services, Business Development, Project Management, Marketing, and Finance. Support Clients by performing the initial review of their Clinical Study protocol(s) to determine if WebEZ is a viable solution for the Client's study(s). Provide feedback to Clients regarding WebEZ capabilities, and details on the price points for the various WebEZ service offerings. Perform WebEZ system demos to showcase WebEZ's capabilities.Produce and report WebEZ metrics to senior executives with a focus on WebEZ revenue, system usage, proposal wins/losses, and opportunities for increased business/revenue.Collect and analyze WebEZ user feedback, and use this information to develop system user requirements that direct WebEZ's software development activities.Initiate client billing for WebEZ services, and perform billing reconciliation activities.Represent WebEZ during internal and external system audits.Provide training for system users.Author and maintain WebEZ SOPs, Forms, User Guides, and external facing presentation materials.Provide Level 2 WebEZ technical support for the call center (24/7/365).

Manage and coordinate all technical and service aspects of Interactive Voice Response/Interactive Web Response (IVRS/IWRS) technology projects. This includes the ability to review clinical study protocols, prepare RAMOS IRT Contracts, program the IVR / IWRS system per contract specifications, manage testing/validation of IWRS systems, oversee the user acceptance testing (UAT), and develop end user training documents/presentations.Approver of Internal Material Supplies Contract which is based on study protocol, supply strategies/projections, label/pack strategies, and IRT capabilities.Responsible for completing project work to the customer/sponsor’s satisfaction, and ensuring that quality deliverables are produced both on time and in accordance with SOP’s/policies.Ability to manage the study following IRT system activation.Attend and present at study Kick-off Meetings with the ability to travel domestically and internationally.Lead Customer Complaint/Deviation investigations as necessary, and provide training to the team to summarize the investigation findings.Lead L1 Audits, and prepare audit summaries for both management and QA.Skilled in the use of Business Object Reports for generating various clinical study reports.Well versed in the use of Excel’s pivot table/chart functionality for the production of metrics to monitor and report on team's key business processes (quality, productivity, etc). Competent Visual Basic (VBA) programmer for programming in Microsoft Outlook, Excel, etc.Skilled at leading, facilitating, and documenting the outcomes of weekly RAMOS team meetings. These meetings are highly technical in nature, and are highly interactive for meeting participants. Skilled at logging/managing help-desk tickets for L1/L2 RAMOS tech support.Proven ability to think logically and analytically while managing risks (both anticipated and unanticipated risks). Skilled at developing and implementing successful risk mitigation strategies.

Over 10 years experience in cGMP process development labs doing API chemical synthesis, synthetic route development, pilot plant manufacturing, analytical testing, and API batch release documentation.Experience documenting and recording process deviations in a manufacturing environment.Effective at determining the root cause for quality incidents, and then implementing CAPAs to prevent re-occurrence of incidents.Routinely worked within validated electronic systems and software packages. Experience with regulatory documents in IMMS, and scientific reports/data in Documentum and IMMS.Accustomed to working in a highly regulated pharmaceutical environment, and working within various guidance documents: SOPs, cGMP documents, Compendium of Analytical Procedures, ICH (Q3A-Q3D, and Q6A) guidelines, and USP General Notice documents.Oversee the Batch Release of cGMP quality API by coordinating the analytical testing and preparing the GMP batch release documentationContributor to Regulatory Documents for Retigabine and GSKxxxxx22. (NDA and IMPD documents).

Conducted discovery research as a medicinal/synthetic chemist in the field of oncology.