Summary
Overview
Work History
Education
Skills
Websites
Extendededucationandtraining
Professionalaccomplishments
Timeline
Generic

Charles Nagel

Cartersville,Georgia

Summary

Dedicated Program Leader with over 21 years of experience in the clinical data and the clinical research industry, specializing in Clinical Data Systems, Alliance Management, Contracts Project Management and Customer Success. Proven expertise in overseeing/ leading complex contracted Clinical IT projects and programs ensuring their success through planning and execution. Entrepreneurial and creative Founder passionate about turning innovative ideas into tangible results. Experienced formulating and executing strategic plans, creating new products and services, and developing business opportunities. Track record of multiple successful business ventures and leading teams of professionals to maximize profits and deliver success.

Overview

29
29
years of professional experience

Work History

Founder and Operator

Nagel’s Bagels
09.2022 - Current
  • Buildout 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.
  • Self-motivated, with a strong sense of personal responsibility.
  • Worked effectively in fast-paced environments.
  • Skilled at working independently and collaboratively in a team environment.
  • Excellent communication skills, both verbal and written.
  • Worked well in a team setting, providing support and guidance.

Sr. Program/ Digital Project Manager

Oracle Corporation
11.2016 - 09.2022
  • Managed contract IT software solution implementations for pharmaceutical companies for Oracle digital products through contract negotiations and project continuance
  • Oversaw product functionalities and performance reporting, troubleshooting IT issues, and handling escalations for successful project execution directly with customers and vendors
  • Managed customer driven proposals for process and product improvements or enhancements
  • Managed directly with customers and vendors to provide summary status updates to multiple levels of stakeholders
  • Key Achievements: Contractually, I Led the migration and upgrade of the Oracle InForm platform for over 100 studies spanning 30 customers
  • Managed real-time support for product escalations, maintaining customer relationships and communication pathways
  • Ensuring adherence to contract expectations and deliverables
  • Confirmed the accurate skill set by reviewing and coordinating, scheduling and conducting interviews of candidates for team positions
  • Facilitated strategic sourcing for cross-functional communication with Product Management to confirm customer updates and change management progress which often led to potential cost savings
  • Organized and training for high-level meetings for contract kickoff, maintenance, and closeout, ensuring effective communication
  • FDA Audits for compliance and quality.

Sr. Clinical Data Lab Analyst

Quintiles/ Q2 Solutions
04.2014 - 11.2016
  • Ensured 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 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.

Program Manager

US Data Management
08.2013 - 01.2014
  • Oversaw 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.

Sr. Consultant/ Clinical Project Manager

Liaison Technologies
03.2010 - 08.2013
  • Implemented 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.

Electronic Data Capture Project Analyst/ Consultant

Perficient (BioPharm Systems)
09.2006 - 03.2010
  • Implemented EDC software for multiple pharmaceutical companies, managing EDC requirements gathering, deliverable approval, and post-implementation Hyper-care
  • 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 validate 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.

Clinical Data Manager

Synteract Inc.
03.2006 - 09.2006
  • Review 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.

Clinical Data Manager

Ligand Pharmaceuticals
07.2003 - 03.2006
  • Review 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).

Clinical Data Manager

Parexel
04.2002 - 07.2003
  • Review 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.

Biotechnology Representative

RDH Consulting
09.2001 - 04.2002
  • Calibration and operations manual creation of equipment within the Biotech industry
  • Clinical Manufacturing of Parenteral drugs, uncontrolled substances and finished product Quality assessment.

Sr. Production Technician II

Chromagen
07.1999 - 09.2001
  • Elisa Kit preparation and production line inventory control management
  • Assisted other operators with process management and review of proper production line aseptic techniques when handling materials, equipment and supplies in a cleanroom environment.

Quality Assurance Inspector

Alliance Pharmaceuticals
01.1997 - 01.1999
  • Quality inspection of raw materials and finished products from the manufacturing plant and communicate with microbiology and document environmental readings
  • Inspection of bottling, labeling and cleaning procedures to provide an acceptable cleanroom environment for manufacturing.

Sr. Production Technician II

Alliance Pharmaceuticals
10.1995 - 01.1997
  • Production Tech to manufacture liquids and powders of clinical products in a controlled manufacturing plant
  • Bottling, labeling and cleaning of a cleanroom environment.

Education

Associates of Science in Nursing -

Georgia Highlands College of Nursing
01.2026

Bachelors of Science in Business - High-Tech Management

California State University
01.2006

Associates of Science in Biology - Pre-Nursing

San Diego Mesa College
01.2001

Skills

  • IT Project Management
  • Clinical Data Research Expertise
  • Customer/ Vendor Relationship Management
  • Oracle InForm PM
  • Oracle Clinical CDM
  • PMP Preparation
  • Contracts Management
  • Global Team Management
  • Acceptance Testing
  • Clinical Trials
  • IT Migrations and Upgrades
  • IT Application Implementations
  • QA Inspections
  • Customer Escalations
  • Clinical Project Management
  • Project Risk
  • MS Suite
  • FDA Audits
  • Team Leadership
  • Strategic Thinking
  • Marketing
  • Entrepreneurial and Innovative
  • Client Engagement

Extendededucationandtraining

  • Serve Safe Certified- Health Department & Department of Agriculture Food Service Permits
  • Microsoft Proficiency: Outlook, One Note, PowerPoint, Visio, Word and Excel
  • PMP Preparatory Classes
  • Bio-quality concepts I & II

Professionalaccomplishments

  • Successfully led and managed the design and launch of complex clinical research studies for over 15 years.
  • Played a key role in the proposal and business development process through contracting services, contributing to successful bid defense meetings. Specifically in IT Platform Licensing and protocol continuance.
  • Committed to contributing knowledge, skills, and abilities to enhance Project Services systems and elevate project execution to achieve organizational success.
  • Supplier collaborations for kick off and maintenance of contracts and audits. Worked with over 40+ customers to provide services.

Timeline

Founder and Operator

Nagel’s Bagels
09.2022 - Current

Sr. Program/ Digital Project Manager

Oracle Corporation
11.2016 - 09.2022

Sr. Clinical Data Lab Analyst

Quintiles/ Q2 Solutions
04.2014 - 11.2016

Program Manager

US Data Management
08.2013 - 01.2014

Sr. Consultant/ Clinical Project Manager

Liaison Technologies
03.2010 - 08.2013

Electronic Data Capture Project Analyst/ Consultant

Perficient (BioPharm Systems)
09.2006 - 03.2010

Clinical Data Manager

Synteract Inc.
03.2006 - 09.2006

Clinical Data Manager

Ligand Pharmaceuticals
07.2003 - 03.2006

Clinical Data Manager

Parexel
04.2002 - 07.2003

Biotechnology Representative

RDH Consulting
09.2001 - 04.2002

Sr. Production Technician II

Chromagen
07.1999 - 09.2001

Quality Assurance Inspector

Alliance Pharmaceuticals
01.1997 - 01.1999

Sr. Production Technician II

Alliance Pharmaceuticals
10.1995 - 01.1997

Associates of Science in Nursing -

Georgia Highlands College of Nursing

Bachelors of Science in Business - High-Tech Management

California State University

Associates of Science in Biology - Pre-Nursing

San Diego Mesa College

Similar Profiles

CREATE PROFILE
Charles Nagel