Deborah Baldwin

Deborah Baldwin Email and Phone Number

Senior Clinical Operations Specialist ▶︎ Driving Clinical Research Excellence and Regulatory Compliance | Oncology, MedicalDevices, Immunology, Vendor Management, Clinical QA | DEI | Patient Advocacy @ Baldwin Advisory LLC
United States
Deborah Baldwin's Location
Greater Philadelphia, United States, United States
Deborah Baldwin's Contact Details

Deborah Baldwin work email

Deborah Baldwin personal email

About Deborah Baldwin

✉I have dedicated my career as a Senior Clinical Operations Specialist to helping research companies advance life-changing therapies through clinical trials. With expertise in diverse therapeutic areas including oncology, childhood leukemia, cardiovascular stents, and medical imaging, I thrive on delivering practical solutions that advance current trials while improving future trial outcomes. My approach is process-driven, ensuring trials in high-need research areas progress smoothly from Phase I to Phase IV.What drives me? I developed an interest in health care, science, and technology in my early career. I worked with a Principal Investigator who was new to clinical research but aimed to create a space for minorities and people of color to screen for prostate cancer. The sponsor provided the necessary training, and together, we successfully launched and completed the clinical trial. Today, patient advocacy and diversity inclusion remain essential, and our collaborations with sponsors, CROs, sites, and the community significantly improved patient care. This is what fuels my passion for working at the forefront of science and clinical research.At Baldwin Advisory, I lead clinical operations and adverse event analysis for global clients like Pfizer, GE Healthcare, and Merck. My top responsibility is managing pivotal clinical trials, ensuring they adhere to strict protocols and regulatory standards. One of my proudest accomplishments is achieving a 65% increase in monitoring task productivity, which accelerated initiation-readiness for 30 sites and streamlined our documentation process.I've driven investigator recruitment and coordinated study initiation activities at Ascentage Pharma Group, where I trained site staff on EDC systems and ensured compliance with regulatory audits. During my tenure at IQVIA and Merit Medical Systems, I performed on-site monitoring visits, validated source documentation, and resolved data queries to maintain data quality and integrity. I also led study start-up activities for a large-scale psoriatic arthritis study, ensuring prompt initiation readiness for multiple sites. My overarching value offer lies in my ability to enhance regulatory compliance, optimize patient recruitment, and streamline data management processes. I bridge communication gaps between research physicians, leadership, and field teams to ensure seamless trial operations. If we haven’t connected yet on LinkedIn, hit the connect button and join my network. Deborah.Baldwin2008@gmail.com ☏ 267-971-9059

Deborah Baldwin's Current Company Details
Baldwin Advisory LLC

Baldwin Advisory Llc

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Senior Clinical Operations Specialist ▶︎ Driving Clinical Research Excellence and Regulatory Compliance | Oncology, MedicalDevices, Immunology, Vendor Management, Clinical QA | DEI | Patient Advocacy
United States
Employees:
4
Deborah Baldwin Work Experience Details
  • Baldwin Advisory Llc
    Baldwin Advisory Llc
    United States
  • Baldwin Advisory
    Sr. Clinical Operations Specialist
    Baldwin Advisory Oct 2008 - Jul 2024
    Drawing from years of experience as a Sr. Clinical Research Operation Specialist, I launched and grew a clinical research advisory focused on proactive risk mitigation and operational excellence. I manage and oversee pivotal clinical trials for leading organizations, ensuring adherence to rigorous protocols and regulatory standards. My role involves remote monitoring, site initiation, compliance auditing, and data integrity management, facilitating seamless execution of high-stakes clinical research initiatives. I've directed study start-up activities for a non-IND psoriatic arthritis study and resolved regulatory discrepancies for Pfizer, ensuring compliance for ongoing and future trials.
  • Ascentage Pharma
    Senior Clinical Research Associate
    Ascentage Pharma Oct 2021 - Jun 2022
    Suzhou, China, And Rockville, Maryland, United States, Cn
    Here I drove the investigator recruitment process and evaluated potential investigators' capabilities to manage clinical studies effectively. I coordinated activities with multiple sites for study initiation, obtained regulatory documentation, and facilitated the approval of study-specific documents. I trained site staff on the EDC system, ensuring compliance with site audits, and conducted on-site monitoring visits to ensure adherence to Good Clinical Practices (GCP) and validated source documentation.

Deborah Baldwin Skills

Clinical Research Medical Devices Drug Safety Protocol Clinical Trials Regulatory Affairs Gcp Quality Assurance Product Management Ind Oncology Fda Cro Protocol Review System Monitoring Clinical Monitoring Pharmaceutical Industry Vaccines Infectious Diseases Neurology Therapeutic Areas Clinical Quality Clinical Study Design Urology Immunology Data Management Site Management And Initiation Ind Submissions Data Analysis And Monitoring Trial Master File Auditing Gcp And Ich Compliance Monitoring Class Lll Device Trials Clinical Research Associates Product Safety Biomedical Engineering Ivd Medical Imaging Medical Device Reporting Biomarkers Complaint Handling Post Market Surveillance Vendor Management Regulatory Submissions Pma Interventional Radiology

Deborah Baldwin Education Details

  • Temple University
    Temple University
    Biological Science

Frequently Asked Questions about Deborah Baldwin

What company does Deborah Baldwin work for?

Deborah Baldwin works for Baldwin Advisory Llc

What is Deborah Baldwin's role at the current company?

Deborah Baldwin's current role is Senior Clinical Operations Specialist ▶︎ Driving Clinical Research Excellence and Regulatory Compliance | Oncology, MedicalDevices, Immunology, Vendor Management, Clinical QA | DEI | Patient Advocacy.

What is Deborah Baldwin's email address?

Deborah Baldwin's email address is de****@****ott.com

What schools did Deborah Baldwin attend?

Deborah Baldwin attended Temple University.

What are some of Deborah Baldwin's interests?

Deborah Baldwin has interest in Children, Economic Empowerment, Civil Rights And Social Action, Education, Science And Technology, Disaster And Humanitarian Relief, Human Rights, Health.

What skills is Deborah Baldwin known for?

Deborah Baldwin has skills like Clinical Research, Medical Devices, Drug Safety, Protocol, Clinical Trials, Regulatory Affairs, Gcp, Quality Assurance, Product Management, Ind, Oncology, Fda.

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