Jake Flagler
Forney,Texas
Summary
Innovative and results-driven professional with expertise in developing cutting-edge software solutions, ensuring fast and efficient project delivery, and driving excellence in digital product execution. Skilled in strategic planning, cross-functional collaboration, and aligning technical solutions with user needs to deliver impactful outcomes, particularly in patient-facing technologies. Passionate about leading user-centered product initiatives that drive growth and innovation.
Overview
6
6
years of professional experience
Work History
Digital Ops Manager II – Digital Implementation
Accelerated Enrollment Solutions (PPD and Thermo Fisher Scientific)
11.2024 - Current
- Acts as subject matter expert for digital solutions and services both for internal and external stakeholders
- Directs the technical and operational aspects of the digital project in scope of award
- Works with major functional area leads to identify and evaluate fundamental issues on the project, interpret data on complex issues, makes sound business decisions and ensure solutions are implemented
- Works to ensure all project deliverables meet the customer’s time/quality/cost expectations
- Coordinates activities of all functional departments (data management, programmers, testers, global clinical supplies, etc.) and vendors (translation, technology, copyright holders, etc.) involved in the project
- Acts as principal liaison between Sponsor and the organization by facilitating the flow of information between the organization and client
- Provides Sponsor with timely project updates, project related fiscal information, ensures correct protocol interpretations, and obtains direction and feedback on implementing scope of work
- Works closely with finance and legal to manage all financial and contractual aspects of the study including establishing and recognizing financial milestones for invoice and subcontractor purposes, subcontracting with third-party service providers, approving subcontractor invoices
- Works with the project team to establish appropriate controls to ensure that project resources and expenses are aligned with budgets
- Works closely with management to provide details for the development and negotiation of contract modifications, as needed
Project Manager – Patient Recruitment and Technology
Accelerated Enrollment Solutions (PPD and Thermo Fisher Scientific)
08.2022 - 11.2024
- Hosts internal Screener Council sessions twice weekly to monitor and adjust pre-screening and recruitment strategies to meet the everchanging demands of each trial
- Manage sophisticated digital screening platform that integrates pre-screening, virtual first office visit (vFOV), patient portal, and site communications platform
- Debug pre-screeners to identify any loops, mistakes, or discrepancies
- Track actively changing trial priorities to ensure site staff are screening for appropriate trials based on budget, enrollment, and target requirements
- Manage internal and vendor translators in Translation Hub platform to ensure accurate translations and timely completion in accordance with study launch timelines
- Analyze patient data from marketing, pre-screening, vFOV, and site to guide decisions for pre-screening, recruitment, and reengagement
Patient Recruitment Lead
Accelerated Enrollment Solutions (PPD and Thermo Fisher Scientific)
04.2022 - 08.2022
- Own and drive patient recruitment across our trials and site networks via collaboration and analytical data review
- Serve as the conduit of recruitment progress and information sharing over the life of the study
- Maintain all key study documents related to patient recruitment and track risks, key decisions, actions, and results
- Communicates with key internal stakeholders (BD, GPM, OD, Patient Recruitment leads, GSR, and Analytics, Senior Leadership) the initial project recruitment plan and provides updates on any changes to the plan throughout the project lifecycle
- Creates the project plan documentation file and updates as needed and at set intervals
- Hosts portfolio diagnostic review meetings at pre-determined and ad-hoc intervals as agreed upon with stakeholders
- Able to apply knowledge of the business and review all information available to make proactive, strategic decisions/recommendations to enhance the patient, site, and sponsor experience
Program Manager – Patient Recruitment
Accelerated Enrollment Solutions (PPD and Thermo Fisher Scientific)
11.2021 - 04.2022
- Organizing programs and activities in accordance with the mission and goals of the organization
- Developing new programs to support the strategic direction of the organization
- Creating and managing long-term goals
- Developing an evaluation method to assess program strengths and identify areas for improvement
- Managing a team with a diverse array of talents and responsibilities
- Ensuring goals are met in areas including customer satisfaction, safety, quality, and team member performance
- Implementing and managing changes and interventions to ensure project goals are achieved
- Meeting with stakeholders to make communication easy and transparent regarding project issues and decisions on services
- Producing accurate and timely reporting of program status throughout its life cycle
- Analyzing program risks
- Effectively communicating progress to SLT and ESLT
Associate Project Manager/Optimization Specialist
Accelerated Enrollment Solutions (PPD and Thermo Fisher Scientific)
12.2020 - 11.2021
- Supports and collaborates with initiative teams to prepare, organize, coordinate, document, and/or provide the development and delivery of department products and services to a globally dispersed cross-functional audience
- Creates varied support materials, presentations, and/or tools to support the department's remit and strategies
- Prepares, coordinates, and/or delivers working group materials, facilities, and communications per established processes, timelines, and milestones
- Supports and participates in process improvement initiative teams
- Participates in and supports initiatives to develop, optimize, improve, and assess compliance with processes and associated systems/applications, training, and communications
- Undertakes projects, assignments, and administrative tasks per business need
Site Activation Specialist
PRA Health Sciences
07.2020 - 12.2020
- Recruits and evaluates potential sites for project participation, utilizing assessment tools and questionnaires to obtain project required information
- Owns activation and management of assigned sites to ensure adherence to protocol design and proactively coordinates and drives completion of all requirements with urgency and professionalism including but not limited to coordinating all process contributors, escalating status and risks with mitigation plans, leveraging tools and dashboards to monitor timeliness and quality of activation critical path, and meeting high quality documentation requirements
- Performs essential document collection, review, maintenance, submission, notification, and close-out activities, including but not limited to informed consent form (ICF) template(s), ensuring client and investigator obligations are being met and are in compliance with applicable local regulatory requirements, ICH/GCP guidelines, and PRA SOPs
- Performs project tracking to ensure clinical and site management information, including but not limited to project files, site contacts, client communications, and training assignments, are current, accurate, complete, and audit ready
- Liaises with internal and external stakeholders to meet project specific goals, prepares for and participates in investigator and client meetings as necessary, escalates project and site related issues per PRA SOPs, ensures client and investigator obligations are being met and are compliant with local regulatory requirements and ICH-GCP guidelines
- Manages additional clinical operations and project management tasks as required and outlined in job task list
Clinical Project Assistant
Clinlogix, LLC
06.2019 - 07.2020
- Responsible for updating and maintaining study relevant documents
- Clinical sites communications, correspondence and collection of study related documentation
- Support Project Managers, CRAs and Sponsors with development, preparation, handling and distribution of Study Supplies (i.e
- Relevant study binders and packets) and manage distribution status per study
- Set Up study files and maintain records in the Trial Management Systems (TMF, SharePoint, etc.)
- Act as a liaison with partners and vendors with supplies management
- Support sponsors and Project Manager with distributing, requesting, collecting, and reviewing site regulatory documents for the applicable phase of the clinical study (Study Start Up, Enrollment, Follow-Up, Maintenance, etc.), including a precise quality check (QC) when documents are received
- Communicate and provide updates to study team as necessary on all aspects of the study (including but not limited to, collection of regulatory documents, institutional review board (IRB)/ ethics committee (EC) submissions, follow up visit reminders, study close outs, etc.)
- Coordinate study materials and assemble, review, and maintain study specific templates and trackers
- Maintains clinical grant tracking database for each study, generates periodic reports on status of grant payments and resolves payment inquiries from investigator sites
- Support sites to ensure compliance to study protocol, timelines and regulatory guidelines
- Responsible for creating and completing informed consent form (ICF) checklists for applicable sites and studies as needed
- Responsible for maintaining and tracking all study personnel’s up-to-date training status and information
- Collect and review safety source documents provided by sites
- Support sites & study team with study related documents/imaging uploads
- Other project support duties as assigned
Education
Master of Science - Artificial Intelligence
Purdue University
West Lafayette, IN05-2026
Professional Science Master’s (PSM) - Bioinnovation
Temple University
Philadelphia, PA12-2020
Bachelor of Science - Biology
Temple University
Philadelphia, PA05.2019
Skills
- Solutions development
- Project planning and development
- Cross-functional coordination
- Cost reduction
- Key performance indicators
- Forecasting
- Change management
- Regulatory compliance
Previoustraininghighlightstechnicalskills
- ICH-GCP Certification (NIH/NIDA)
- GLP Certification
- Microsoft Office Suites
- Microsoft Teams
- Adobe Acrobat
- SimpleTrials CTMS
- SharePoint, DRS, and other cloud drive eTMF systems
- EDC and other vendor system (iMedNet, IBM, Bioclinica, AG Mednet)
- Central IRB Submission systems (WIRB, Advarra)
- Investigator Grant Payment
- DIA TMF format
Timeline
Digital Ops Manager II – Digital Implementation
Accelerated Enrollment Solutions (PPD and Thermo Fisher Scientific)
11.2024 - Current
Project Manager – Patient Recruitment and Technology
Accelerated Enrollment Solutions (PPD and Thermo Fisher Scientific)
08.2022 - 11.2024
Patient Recruitment Lead
Accelerated Enrollment Solutions (PPD and Thermo Fisher Scientific)
04.2022 - 08.2022
Program Manager – Patient Recruitment
Accelerated Enrollment Solutions (PPD and Thermo Fisher Scientific)
11.2021 - 04.2022
Associate Project Manager/Optimization Specialist
Accelerated Enrollment Solutions (PPD and Thermo Fisher Scientific)
12.2020 - 11.2021
Site Activation Specialist
PRA Health Sciences
07.2020 - 12.2020
Clinical Project Assistant
Clinlogix, LLC
06.2019 - 07.2020
Master of Science - Artificial Intelligence
Purdue University
Professional Science Master’s (PSM) - Bioinnovation
Temple University
Bachelor of Science - Biology
Temple University
Similar Profiles
Adrianne BennettAdrianne Bennett
Medical Information Specialist II- Nurse at PPD, A Part of Thermo Fisher ScientificMedical Information Specialist II- Nurse at PPD, A Part of Thermo Fisher Scientific
Tracey RobertsTracey Roberts
Executive Director, Project Delivery at PPD, Part of Thermo Fisher ScientificExecutive Director, Project Delivery at PPD, Part of Thermo Fisher Scientific
Skylar ReedSkylar Reed
Sr. Automation Specialist, Service at PPD, Part of Thermo Fisher ScientificSr. Automation Specialist, Service at PPD, Part of Thermo Fisher Scientific