Katia Russoniello
Clinical Research Scientist @Shionogi Inc. (U.S.)
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WORK HISTORY
Clinical Research Scientist @Shionogi Inc. (U.S.)
Working with Global Medical Monitor, reviews and interprets clinical data through EDC and relevant data base, drafts high quality patient narratives to a level that would be ultimately acceptable for submission for NDA applications.• Communicates with clinical study site personnel – PI for resolution/finalization of interpretation of data and ID key missing information.• Liaise with other cross-functional teams (Clinical operations, data management, product safety/Pharmacovigilance, regulatory, medical writing and project management) to ensure timely delivery, quality of writing deliverable and problem resolution.• Support Global Trial Lead when participating in marketing and clinical/medical advisory panels [DSMB], steering committees and investigator meetings. Serve as a resource to address medical questions or to clarify issues during conduct of study.• Ensure proper version control of all applicable documents and define, collect, track, and report on metrics.• Assist in reconciliation of clinical/safety database.
EDUCATION
Felician University
BSN, Nursing
Kean University
MPA/minor in health management, Management
Middlesex College
ASN, Nursing
SKILLS
ABOUT KATIA RUSSONIELLO
A DEDICATED Registered nurse with 15 + years of international and domestic pharmaceutical industry experience focusing in Pharmacovigilance, medical writing, drug safety, product labeling, promotional review, global medical affairs,and site training with 36+ years in healthcare. Experienced in following therapeutic areas: Cardiovascular, Respiratory, Anti-Infective, Women’s Health, Osteoporosis, and Anti-fungal.• Successfully direct projects from concept to operational status. Effectively communicate mitigation strategies in matrix organization to ensure successful project implementation. • Decisive leader and team player.• Proficient in understanding, interpreting and evaluating clinical data• Demonstrates strong presentation, communication and leadership skills to manage cross-functional initiatives
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