Veronica Y Email & Phone Number

Basel, Baselstadt, CH

Basel, Baselstadt, CH

• Supports GTD to ensure trial deliverables are met according to timelines, budget, operational include development of specific sections of protocol and related documents; development of study tools; guidelines and.
• Preparation of clinical outsourcing specifications. Responsible for management of Contract Research Organizations (CROs) and other vendors to ensure adherence to scope of work within timelines and budget.
• Supports the development, management and tracking of trial budget items as assigned, working closely with the appropriate partners in Global Development Operations (GDO and GMA).
• Supports GTD in managing interactions with relevant line functions including Data Management, Drug Supply Management and Novartis Country Organizations.
• Contributes to the ongoing scientific review and validation of the clinical data.
• Supports GTD in the development of Case Report Forms (CRFs), edit checks, CRF completion guidelines, data review reports and trial statistical analysis.

• Sponsor monitor (CRA): managed up to 11 KOL sites per clinical trial phase III studies and clinical trial vendor(s) such as ACM.
• Assisted in investigator study site selection and study start-up.
• Committee reviewer for clinical project documents according to the protocol, including, but not limited to, source documentation forms and guidelines, monitoring Standard Operating Procedures (SOPs), monitoring visit.
• Implemented and monitored clinical trials to ensure sponsor/investigator obligations were met and compliant with applicable local requirements and FDA and ICH guidelines.
• Conducted co-monitoring visits for CRO managed trials and monitored trials for US-based studies in accordance with protocol compliance, assessed qualifications of study personnel, and ensured “Good Clinical Practice”.
• Identified site issues and initiated correction plans based on monitoring reports.

Rockaway, New Jersey, US

• Participated in site feasibility evaluations and site selection process.
• Coordinated activities related to multi-center investigator meetings.
• Conducted site initiation visits, monitoring and close out visits.
• Assisted and developed study start-up activities including, but not limited to essential document review and submission.
• Participated in data review, query resolution and oversight of clinical staging process.
• Tracked progress of project related deliverables according to SOPs and Clinical Work Instructions.

Leverkusen, North Rhine-Westphalia, DE

• Supported study team with feasibility documents, study start-up process, Power Point presentations, coordinated mass mailings to clinical sites for distribution in Investigator Site files, developed/authored.
• Supported study team in processing regulatory documentation.
• Prepared, circulated, and tracked documents.
• Maintained various clinical trial trackers and spreadsheets.
• Managed the Trial Master File.
• Updated study progress in IMPACT database.

Fair Lawn, New Jersey, US

• Assisted and managed two Dermatology Phase III studies and two Extension studies simultaneously.
• Assisted with reviews of CRA visit reports, protocol deviation reports, drug reconciliation logs, patient visit logs, and SAE/AE reports.
• Assisted with study start-up, maintenance and close out of pharmaceutical clinical trials.
• Assisted PM with Quality Control (QC) review and managed Trial Master Files in preparation for audit reviews.
• Served as liaison by interacting directly with multiple study personnel including but not limited to: vendors, CRAs, clinical research sites, data management, and sponsors.
• Assisted with submissions to the FDA, Central Institutional Review Board and Local Institutional Review Board

Bedminster, NJ, US

-Conducted on-site clinical co-monitoring which included: document review, ensured accurate data recording, verified patient data, adherence to the protocol of a clinical trial in accordance with GCP/ICH guidelines, and sponsor's SOPs.-Performed on-site visits including site qualification, initiation, co-monitoring and close-out visits.-Assisted PDs, PMs.

• Assisted with the pharmaceutical development of INDs.
• Reviewed and compared patient information for consistency between CRF and clinical study site source documents.
• Conducted patient recruitment, screening, and enrollment processes.
• Co-chaired patient data review meetings and performed patient follow-up.
• Assisted CRC with clinical study reports in accordance with regulatory guidelines.
• Involved with CRF development database entry.

Washington, DC, US

• Assisted FDA and USDA affiliated research scientists and veterinarians working on projects for the National Antimicrobial Resistance Monitoring System.
• Assisted in writing articles for renowned journals, i.e. Emerging Infectious Diseases, Food Safety Magazine, and Annals of Epidemiology.
• Performed laboratory work on bio-hazardous bacteria, i.e. diphtheria, campylobacter, salmonella, and e-coli.
• Authored research presentations utilizing research data and surveys.
• Advanced knowledge of food microbiology, animal nutrition, and animal/human diseases.
• Utilized MS Excel, Word, Power Point, Access, Publisher, Outlook, GroupWise, and scientific libraries to coordinate research projects, budgeting campaigns, scientific current events, and miscellaneous work for.

Animal Science/Pre-Vet Med

Master’S Degree, Clinical Trial Management