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Education

Doctorate in Health Sciences: September 2024

A. T. Still University, Kirskville, MO

               Applied Research Project: Perceptions of Emergency Medical Services (EMS ) on the Ability to Satya Engaged in the Field Over TIme

                A.T. Still University Students Association

A.T. Still College of Health Sciences Student Council 

 

Executive Master of Sciences in Management: October 2020

Wilmington University, Wilmington DE

                  Thesis: Project coordination will lead to better performance outcomes

                  Adviser Dr. Clinton Robertson, Assistant Dean

                  Wilmington University Student Governing Association

 

Certificate in Innovation and Entrepreneurship: May 2017 

Rowan University, Glassboro NJ 

                  Faculty Center for Excellence in Teaching & Learning

 

Master of Sciences in Biology, Concentrations in Microbiology and Molecular Biology:  May 2013

Rutgers University, Camden NJ

                  Thesis: Co-Regulation of Q8IYR2 Protein for Better Protection

                  Advisers Dr. Daniel Shain, Chair of Biology Department and Dr. Samuel Adhikari, Henry Rutgers Term Chair

Rutgers University Board of Trustees Graduate Student Representative

Rutgers Presidential Accommodation for Service to University 

Rutgers Presidents Council

 

Bachelor of Arts in Biology and Psychology, Minor in Finance: May 2009

Rutgers University, Camden NJ

                    Student Government Presidential Leadership Award

                    Dean’s Undergraduate Research Prize

                    Sandy Stewart Scholarship in Biology

                    Peer Mentor of the Year Award

 

Experience

Senior Specialist, Merck & Co

October 2020-Present

                Provide detailed technical and operational control over project management and administrative process within Nonclinical Drug Safety                       (NDS).
               Lead multimillion-dollar project planning, development, and execution of integrated lab modernization effort across the entire Merck                             Research Labs (MRL) landscape. Collaborate and coordinate single sources activities of necessary equipment and project personnel to                           ensure project progresses on schedule by formulating and define scope and objectives.

 

                Establish work plan and staffing for each phase of projects, and arrange for recruitment or assignment of project personnel, assign duties,                    responsibilities, and scope of authority to project personnel.

 

Adjunct  Associate Professor, Rowan University

August 2015- Present

Teach classes: Evolution, Diversity and Adaptation, Introduction to Genetics, Microbiology, Communication Biology and Human Biology to college major and non-major students.

 

Instruct the theoretical and practical applications approach to modern life sciences. Create, code and manage the online interactive portion of the class utilizing the Blackboard Learning Management System (LMS).

 

Principal, DJS McArdle LLC

May 2019 – Present

Provide consulting and startup services to clients in the life sciences services. Expert understanding the cGxP software

development process, including requirement gathering, analysis/design, development tools/technologies, release/version control, contemporary testing methodologies and deployment management. Interface with LIMS management software and serve as an expert liaison to clinical departments. Able to act as the team lead for system alignment for back end development and technical analyst for problem solving. Serve as public health policy liaison. 

 

Expert on large data management systems including Veeva Vault, Xpress, eTrack, JIRA, R, and Python and others with

advanced understating in system alignment. Monitor and identify trends, completeness tracker, and performance. Develop and deliver training materials internally and externally. Expert understanding of lot management and lot delivery release.

 

QC Operations Scientist, Eurofins (On assignment at Merck & Co)

October 2019 - Present

               On assignment to Merck Manufacturing (MMD) where I provide senior technical and analytical operations support for quality control,                            quality assurance and validation control for Good Manufacturing Practice (GMP) equipment and processes. Author and validate quality                        documents for BVA as needed.

 

                Co-Lead Biologics and Vaccines Analytics (BVA) capital purchasing program responsible for $3.5 million of new capital annually. 

 

 

Senior Business Analyst, Research Life Sciences,  Atlas Data Consulting (On assignment to Merck & Co)

February 2019-May 2019

Technical and organizational expertise for a division wide data readiness and resiliency integration project. In the group, I provided data development, conversion, design and implementation of business analytics, planning, and reporting tools for project and senior management. Additionally, I lead the interface for quality control and governance to targeted solutions within the larger resiliency Merck Research Labs division (Safety & Assessment, Quality Control, Biologics Pilot Plant, and Clinical Trials). Create and manage reporting and training analytic strategies for more synchronous alignment. Drive user-friendly reporting across functional and business areas to create a long-term solution.

 

Interface with the Project Management Organization (PMO) and senior leadership in MRL to provide solutions for assigned projects. Serve as public health policy team lead. Expert on large data management systems including Veeva Vault, Xpress, eTrack, JIRA, R, and Python and others with advanced understating in system alignment. Monitor and identify trends, completeness tracker, and performance. Develop and deliver training materials internally and externally. Expert understanding of lot management and lot delivery release.

 

Business Analyst, eClinical Operations, Research & Development Global Clinical Operations, CGI Group (On assignment to BMS and CSL Behring)

March 2018- November 2018

Responsible for large-scale data eTMF processes for Phase 1-4 clinical trials. Serve as primary point of contact with for study teams and liaise with SME to ensure that the eTMF is inspection ready at all times.

 

Expert understanding the cGxP software development process, including requirement gathering, analysis/design, development tools/technologies, release/version control, contemporary testing methodologies and deployment management. Interface with LIMS management software and serve as an expert liaison to clinical departments. Able to act as the team lead for system alignment for back end development and technical analyst for problem solving.

Lead quality assurance, governance, and quality control oversight of all documents as they relate to the management of completed and ongoing clinical trials. Ensure that documentation is consistent with SOPs, ICH, and GCP with no deviations.

 

Act as clinical liaison to scientists for lab clinical based operations including HPLC, PCR, assays, flow cytometry and others. Health policy team member.

Expert on large data management systems including Veeva Vault, Xpress, eTrack, JIRA, R, and Python and others with advanced understating in system alignment. Monitor and identify trends, completeness tracker, and performance. Develop and deliver training materials internally and externally. Expert understanding of lot management and lot delivery release.

 

Clinical Study Associate, TMF Analyst, Global In Country Clinical Operations ZeroChaos (On assignment to GlaxoSmithKline)

May 2017-October 2017

Research Co-Op, Clinical Development ZeroChaos (On assignment to GlaxoSmithKline)

August 2016-April 2017

Clinical Internship, Diagnostics & Clinical Microbiology ZeroChaos (On assignment to GlaxoSmithKline)

May 2016-August 2016

 

Responsible for the creation and update management of eTMF indices for completed studies that are in scope for indexing and migrating. Assist in the management of a large-scale Phase 2B, 10 country influenza clinical trial by working closely with the Clinical Sciences Lead, Operational Sciences Lead, and Medical Monitoring Lead, and Biologics & Manufacturing Pilot Plant Lead. In conjunction with team, establish work plan and staffing for each phase of projects, and arrange for recruitment or assignment of project personnel, assign duties, responsibilities, and scope of authority to project personnel. Coordinate activities of project personnel to ensure project progresses on schedule by formulating and define scope and objectives. Expert understanding of GMP, GCP, and GLP including how labs function with business processes.

 

Maintain data on FDA Requests and Submittals, Site IRB submissions, Northern Hemisphere Flu Incidence Levels,

Communications, Project Operations, Human Biological Sample Management, and others as directed. Confer with project staff to outline work plan, identify, and schedule project deliverables, milestones, and required tasks. Interface with 3rd party vendors to ensure on time and on budget deliveries.
 

Update team weekly with new information by preparing project reports for management. Trained on large data systems including Xpress, eTrack, Pharma eTMF, InForm, PEIR, eDx, and others. Confer with project personnel to provide technical advice and to resolve problems. Coordinate project activities with activities of business units
 

Lead large scale Investigator Meetings and Trainings, Clinical Study Associate Meetings and Trainings, Pharmacists Trainings, and others as directed. Coordinate and respond to requests for changes from original specifications

 

Publications

DH Shain, R Saunders, SLang, MD Tetraeu, MS Dinapoli, AS Egiazarov, SL Gipple, MR Maghirang, DJ Swartley McArdle, SR Yudkovitz, RJ Dial “Population Dynamics and Evolutionary History of North American Glacier Ice Worms” Molecular Phylogenetics and Evolution

 

Presentations

McArdle, DJS. Physiologic Approach to Resistance. HOSR Sciences Fair. Presentation. University of Pennsylvania. November 2017. Philadelphia, PA.

McArdle, DJS. Antibiotic Resistance, and What to Do About It. College of Science and Mathematics (CSM) Science Day, Rowan University. May 2017. Glassboro, NJ.

McArdle, DJS. Big Data and its Impact on the Life Sciences. Science and Media Awards and Summit in the Hub. September 2016.Boston, MA.

McArdle, DJS. Bioinformatics and How It Can Aid in Immune Recovery. Rutgers University. Dean’s Graduate Research Day. November 2013. Camden, NJ.

McArdle, DJS. A Closer Look at the C. elegans Immune Response. Yale University. October 2012. New Haven, CT.

McArdle, DJS. Daucus Roots and Fungi, Potassium and Nitrogen. Cheating Partners. University of Bremen. January 2009. Bremen, Germany.

McArdle, DJS. Interactions and Modifications of the Plant and Fungi. Rutgers University. Dean’s Research Day. November 2006. Camden, NJ.

 

Professional and Organizational Memberships

American Association for the Advancement of Science (AAAS) Member, 2009-Present

American Society for Microbiology (ASM) Member, 2008-Present

                  National Conference, Abstract Reviewer 2017-Present

                  Eastern PA Branch of ASM Treasurer, 2023- Present

National Organization of Gay and Lesbian Scientist and Technical Professionals (NOGLSTP) Member, 2010-Present

                  National Conference Committee, Member, 2016-Present

Out in Science Technology Engineering and Math (oSTEM) Member, 2014-Present

                  Leadership and Education Program, Assistant Vice President, 2018-2020

                  2015 National Conference Outreach Committee, Member, 2015               

Rowan University Medical Faculty Learning Community (FLC) Member, 2016-Present

 

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