Deborah san Juan
Clinical Compliance | Trial Management | Regulatory Affairs | Project Management | Quality Management | Medical Device | Pharmaceutical
- Role
- Principal Clinical Affairs Specialist at Bracco Medical Technologies
- Location
- Chicago, IL, US
- LinkedIn followers
- 500 followers
About Deborah san Juan
Experienced clinical professional with 7+ years of experience in driving compliance to…
Experience
Principal Clinical Affairs Specialist
Jun 2024 — Present
Accurately track and consistently meet compliance deliverables relevant to clinical studies and research, including the development of Clinical Development Plans (CDP), Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF) Plans and Reports, and Summary of Safety and Clinical Performance (SSCP) Reports. • Create and/or revise Clinical Affairs Standard Operating Procedures (SOPs). • Review proposals for investigator-initiated studies for alignment with business needs and in collaboration with marketing. • Collaborate with biostatisticians on the creation of statistical analysis plans and reports. • Provide ad-hoc literature reviews as requested by cross-functional colleagues or teams. • Serve as the clinical lead for creating/editing clinical claims matrices for multiple products, working collaboratively on inter-departmental teams. • Identify and effectively manage third-party vendors for outsourced Clinical Affairs work. • Provide competitive clinical trial analysis on assigned products as needed. • Support development of communications and labeling materials. • Serve as an internal expert on emerging, leading and market differentiating clinical topics.
Education
Saint Louis University
B.S in Biology; MS in Biology; 1 year Med School
Northeastern Illinois University
M.S. in Biology
Skills
- Molecular Biology
- Biochemistry
- Analytical Chemistry
- Cell Biology
- Immunology
- Validation
- Chemistry
- R&D
- Purification
- Elisa
- Hplc
- Chromatography
- Protein Chemistry
- Capa
- Fluorescence
- Pcr
- Cell Culture
- Western Blotting
- Laboratory
- Sop
- Assay Development
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