Jesse Samuel, Mba

Jesse Samuel, Mba Email and Phone Number

Application Product Owner @ ICON plc
New Hill, NC, US
Jesse Samuel, Mba's Location
New Hill, North Carolina, United States, United States
Jesse Samuel, Mba's Contact Details
About Jesse Samuel, Mba

I value and appreciate working in an industry where our work directly contributes to the lives of many patients worldwide. I have a wealth of experience in the pharmaceutical CRO industry culminating in the management of large-scale global clinical trials. I have brought this experience to work on internal project management technology and systems. I am an expert in advanced use of Microsoft Applications and am very technically proficient. I'm a confident leader, skilled speaker, presenter, meeting chair, and trainer. I am able to build positive team & sponsor relationships, create a cooperative and responsive environment, drive cross-functional teams to meet deliverables, be watchful in maintaining study/project budgets, think globally and improve methodologies and workflows to better support the workload of multiple roles, and learn whatever is necessary to successfully achieve a goal or do a task with more quality and efficiency. I focus on enabling my teams with the tools and improved processes they need to create efficiencies that decrease workload and promote success.

Jesse Samuel, Mba's Current Company Details
ICON plc

Icon Plc

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Application Product Owner
New Hill, NC, US
Website:
iconplc.com
Employees:
33970
Jesse Samuel, Mba Work Experience Details
  • Icon Plc
    Application Product Owner
    Icon Plc
    New Hill, Nc, Us
  • Icon Plc
    Project Management Systems Product Management Lead
    Icon Plc Jul 2021 - Present
    Dublin, Ie
    o Aid in the development of internal project management software with a focus on Study Start-Up with site activation and subject enrollment as well as timeline management and milestone risk analysis.o Change management and implementation of internally developed systems to the entire organization.o Manage key stakeholders in the development of the internal systems.o Manage a global central support team that responded to user Helpdesk tickets for internal systemso Represent project managers and end users in system development to enhance the user experience.o Implement training plans and overseeing the training of staff on internal systems.o Manage and contribute to the integration of internal systems to integrate/share data for higher efficiency and elimination of duplicate data entry.o Help to develop project management processes and methods.o Manage direct reports and encourage their growth and development.o Create training plans for system and subject matter experts (SMEs) to support users in the use of internal systems.o Performed UAT on system releases and wrote UAT scripts for testing.
  • Pra Health Sciences
    Senior Project Manager
    Pra Health Sciences May 2019 - Jul 2021
    Raleigh, North Carolina, Us
  • Pra Health Sciences
    Project Manager
    Pra Health Sciences Aug 2013 - May 2019
    Raleigh, North Carolina, Us
    o Managed multi-million dollar clinical trials of different phases (Phase II through Phase III) and various lifecycle stages (i.e. start-up, maintenance, study closure) for pharmaceutical Sponsorso Developed multi-level project timelines and led a diverse cross-functional team in a matrix environment to meet key interim and end-of-study milestones and deliverables on-time and within-budgeto Responsible for reporting to and interfacing with pharmaceutical Sponsorso Oversight of all areas of a clinical trial including study team management and training, study start-up, site qualification & activation, vendor management, monitoring & source data verification, executive reporting to sponsors, data management and database go-live, safety, regulatory approvals, medical writing and protocol development, data reporting and analysis, interim analyses, primary analyses, database lock, and site and study closure.o Drafted and reviewed study management & operational documents (i.e. Project Management Plan, Communication Plan, etc.)o Managed million-dollar project budgets and facilitated change orders and invoicingo Ensured compliance with internal quality (SOPs), confidentiality (HIPAA, ICH), regulatory (i.e. FDA, 21 CFR Part 11, etc.), and Good Clinical Practice (GCP) standards across all projects
  • Intrinsic Imaging
    Project Manager
    Intrinsic Imaging Jan 2012 - May 2013
    City, Us
    o Managed clinical trials of different phases (Phase II through Phase IV) and various lifecycle stages (i.e. start-up, maintenance, study closure) for pharmaceutical Sponsorso Developed multi-level project timelines and led a diverse cross-functional team in a matrix environment to meet key interim and end-of-study milestones and deliverables on-time and within-budgeto Developed and improved key operational procedures and trained the study operational teamo Implemented operational technology to faciliate the medical imaging reviews and workflowo Managed independent radiology reviews by radiologistso Ensured compliance with internal quality (SOPs), confidentiality (HIPAA, ICH), regulatory (i.e. FDA, 21 CFR Part 11, etc.), and Good Clinical Practice (GCP) standards across all projectso Responsible for reporting to and interfacing with pharmaceutical Sponsorso Managed million-dollar project budgets and facilitated change orders and invoicingo Drafted and reviewed study documents (i.e. Imaging Charter, Reviewer Manual, Data Transfer Agreement, Project Plan)o Managed vendors and partners to fulfill contractual duties to the pharmaceutical Sponsors
  • Parexel
    Project Manager
    Parexel Aug 2008 - Jan 2012
    Durham, North Carolina, Us
    o Managed clinical trials of different phases (Phase I through Phase IV) and various lifecycle stages (i.e. start-up, maintenance, study closure) for pharmaceutical Sponsorso Developed multi-level project timelines and led a diverse cross-functional team in a matrix environment to meet key interim and end-of-study milestones and deliverables on-time and within-budgeto Managed independent radiology reviews by radiologistso Ensured compliance with internal quality (SOPs), confidentiality (HIPAA, ICH), and regulatory (i.e. FDA, 21 CFR Part 11, etc.) standards across all projectso Responsible for reporting to and interfacing with pharmaceutical Sponsorso Managed million-dollar project budgets and facilitated change orders and invoicingo Drafted and reviewed study documents (i.e. Imaging Charter, Reviewer Manual, Data Transfer Agreement, Project Plan)o Managed study-specific software and application development to support the clinical trial
  • Parexel
    Medical Research Scientist
    Parexel Oct 2006 - Oct 2008
    Durham, North Carolina, Us
    Responsibilities include medical assistance to all clinical trial projects, including directly assisting the Medical Directors, medical acceptance testing (MAT), preparing and executing independent reviewer training presentations, quality control of the central independent review, and ensuring project adherence to contractual obligations, federal and internal security and confidentiality measures, and the correct usage of analysis criteria (RECIST, Cheson, WHO, Choi, etc.) during the review process.
  • Parexel
    Imaging Research Associate
    Parexel Nov 2005 - Oct 2006
    Durham, North Carolina, Us
    My main functions in this position were to manage the receipt of medical images in clinical trials from sites around the globe, performed data entry to log received packages into the system, processed the images to prepare them for central radiologist review, and issue and resolve queries on images that were not complete or were not of satisfactory quality. I worked with project teams on projects for several various pharmaceutical clients and participated in a dynamic, high-paced environment. I was also responsible for making measurements on images and assisting the project manager with client needs.
  • Boston Sports Clubs
    Personal Trainer
    Boston Sports Clubs May 2005 - Apr 2008
    I work with clients to improve their physical fitness, health, and well-being. My background in Psychology and Neuroscience has been very helpful in both working with clients and understanding how the body works and how to make it perform better or correct muscular imbalances and ineffeciencies. My Personal Training certification came from the National Acadamy of Sports Medicine with a specialty certification in Neuromuscular Stretching. I train in all areas of fitness (strength, weight loss, endurance, etc), but specialize in neuromuscular manipulation and motor programming, posture assessment and correction, joint pain relief and rehabilitation, improving muscular balance, and improving balance and neuromuscular reactivity.
  • University Of Massachusetts
    Research Associate
    University Of Massachusetts Jun 2004 - Nov 2005
    Boston, Massachusetts, Us
    Conducted fMRI research and analysis with Multiple Sclerosis, Alzheimer's disease, and central nervous system executive function, motor processing and execution, visuospatial processing and execution, semantic visuaspatial processing and execution, working memory processing and execution, and default network (consciousness) processing and execution.

Jesse Samuel, Mba Skills

Clinical Trials Oncology Clinical Research Pharmaceutical Industry Medical Imaging Cro Gcp Clinical Development Mri Biotechnology Neuroscience 21 Cfr Part 11 Ctms Project Management Sop Edc Fda Ms Project Microsoft Office Project Planning Clinical Data Management Clinical Monitoring Cross Functional Team Leadership Drug Development Ich Gcp Therapeutic Areas Singing Quality Management Central Nervous System Psychology Ms Office Suite Excel Formula/macro Ct Pet X Ray Mba Vocal Performance Personal Training

Jesse Samuel, Mba Education Details

  • Bellevue University
    Bellevue University
    Business
  • Gordon College
    Gordon College
    Music

Frequently Asked Questions about Jesse Samuel, Mba

What company does Jesse Samuel, Mba work for?

Jesse Samuel, Mba works for Icon Plc

What is Jesse Samuel, Mba's role at the current company?

Jesse Samuel, Mba's current role is Application Product Owner.

What is Jesse Samuel, Mba's email address?

Jesse Samuel, Mba's email address is je****@****ail.com

What schools did Jesse Samuel, Mba attend?

Jesse Samuel, Mba attended Bellevue University, Gordon College.

What are some of Jesse Samuel, Mba's interests?

Jesse Samuel, Mba has interest in Programming, Children, Computers, Biotechnology, Civil Rights And Social Action, Politics, Education, Environment, Science And Technology, Music.

What skills is Jesse Samuel, Mba known for?

Jesse Samuel, Mba has skills like Clinical Trials, Oncology, Clinical Research, Pharmaceutical Industry, Medical Imaging, Cro, Gcp, Clinical Development, Mri, Biotechnology, Neuroscience, 21 Cfr Part 11.

Who are Jesse Samuel, Mba's colleagues?

Jesse Samuel, Mba's colleagues are Prashant Kharat, Tatyana Marchuk-Zhurkova, Cuong Bui, Caparros S., Ali Akbar, Luiz Felipe Araújo Bastos, Carrie Hoppe.

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