Daniela Carroll, Phd Email & Phone Number

Responsible for authoring Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Summary of Safety and Clinical Performance (SSCP), Periodic Safety Update Report (PSUR), and Post Market Clinical Follow-up (PMCF) Plans and Reports for Class III medical devices.

United States

Supports the development of Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), and Post Market Clinical Follow-up (PMCF) Plans for Class III medical devices. Ensures that all documents are well organized, scientifically accurate, consistent, and in compliance with Standard Operating Procedures, MEDDEV 2.7/1 revision 4, and EU MDR 2017/745. Assists in developing training materials for new medical writers and internal template updates.

Indianapolis, Indiana, United States

Critically evaluated published scientific and clinical literature to advance research objectives and secure over $130,000 in grant funding over a period of 24 months. Simultaneously managed 2 preclinical research projects and supervised 2 junior scientists and acted as a subject matter expert in allergic inflammation within the team.

Dallas/Fort Worth Area

Independently conceived and managed a project to identify novel, glycosylation-specific molecular targets for the treatment of intestinal inflammation, leading to 1 first-author publication. Initiated and managed collaborations within UT Southwestern and 2 additional institutions to enhance technical skills and acquire new tools to further support project progression.Demonstrated effective written and verbal communication, and strong analytical skills resulting in 3 grant applications, 1 manuscript and 2 scientific conferences.Supervised 4 doctoral and medical program students and provided technical/scientific consultation to junior scientists.

Advisor: Dr. Bruce Bochner, M.D.Department of Medicine, Division of Allergy and ImmunologyThesis: “A changing perspective on eosinophil Siglec-8 signaling: functional characterization in humans and mice”Independently designed and performed experiments to characterize a molecular target currently in Phase II/III clinical trials for the treatment of allergic inflammation, leading to 2 first-author publication, 1 supporting publication and a doctoral thesis.Collaborated within a cross-functional team encompassing 5 institutions to advance research objectives, leading to 2 publications. Assisted in developing and leading a training workshop, instructing scientists from 4 different institutions on methodologies used for primary human and mouse immune cell isolation and in vitro analysis of immune responses.Participated in organizing committees for 1 national and 1 international scientific conference. Tasks included abstract selection, critical evaluation of scientific presentations and leading scientific discussions with peers. Developed and delivered compelling scientific presentations at local, national and international meetings also receiving $4000 in awards for outstanding scientific presentations.

Lisle, Il

Advisor: Dr. Robin Pals-RylaarsdamIndependently performed in vitro experiments to identify novel intragenic suppressor mutations of G protein-coupled receptors (GPCRs) for the treatment of McCune Albright Syndrome, leading to 2 publications and an award for outstanding poster presentation.

Maywood, Il

Advisor: Dr. Saverio Gentile, Ph.D. Independently performed in vitro experiments to examine the effects of pharmacological ion channel modulators on cancer cell proliferation and survival.

Certificate, Regulatory Affairs Certificate: Medical Devices And Pharmaceuticals (Dual)

Certificate, Oraq Regulatory Affairs Training Program

Doctor Of Philosophy (Phd), Allergy And Immunology

Master'S Degree, Clinical Investigation

Bachelor Of Science (B.S.), Biochemistry/Molecular Biology