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 training materials; management of clinical study material; oversight of vendors and other third parties; implementation of issue resolution plan; conduct clinical data review/procedures, quality/compliance and performance standards. • 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.• Drafts Clinical Trial Team (CTT) meeting minutes. Supports and facilitates some of the topics of CTT and International Clinical Team meetings (ICT).• Organizes and chairs trial sub-teams within the scope of his/her delegated responsibilities.• Prepares training materials and presentations related to the planning and conduct of the trial.• Assists with program level activities (e.g., development of clinical sections of regulatory documents such as Investigators’ Brochures, DSUR/PSUR).• Responsible for education, implementation and compliance to standards (SOPs) and best practices for trial management within GDO and GMA, including sharing lessons learned.• Contributes to talent development in GDO through participation in on-boarding.

• 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 templates and reports.• 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” throughout the life cycle of clinical trials.• Identified site issues and initiated correction plans based on monitoring reports.• Performed investigative site file reconciliation requests on any new and updated site-related essential and non-essential documents and reviews them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, project Standard Operating Procedures (SOPs), and sponsor requirements.• Verified data in source documents in agreement with source, initiated data query resolution and confirmed resolution in timely manner.• Ensured subject safety and adverse event reporting to sponsor and IRB/IEC.• Verified drug accountability logs and storage requirements.• Responded to requests from investigative sites in a timely fashion.• Provided study status updates to team members and project management, including interaction to resolve site issues and facilitated project timelines.

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.• Authored and provided feedback for developing/updating SOPs and Clinical Work Instructions.• Coached clinical sites to ensure adherence to project timelines such as subject recruitment, randomization and database lock phase.• Coordinated, monitored and managed the integration of CRO services as necessary.• Participated in preparation of CRF and protocol development.• Coordinated preparation of Trial Master File.• Coordinated tracking and deployment of grant-in-aid funds.• Wrote, prepared, and approved trip reports related to study.• Provided critical support to regional CRAs and investigational sites for fielding study-related questions.• Established, developed and maintained efficient communications network among internal resources and external partners (sites, CROs, SMOs).• Prepared project status and reports for management review.• Acted as a conduit of information from medical, biometrics to sites and vice versa.• Provided critical assessment of CRO, investigator sites and other outside vendors.• Participated in development of data management plan.• Adjusted role and responsibilities in light of changing business needs.• Proactive in identifying professional development opportunities. • Shared findings and “Best practices” for continued monitoring improvement with colleagues and staff members.• Provided training and coaching to junior level CRAs.

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 newsletters, managed/handled of all study documents, and generated various correspondences to Principle Investigators. • 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.• Generated business objects reports. • Performed quality check of master study files. • Supported study team with study start-up and close-out activities.

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• Assisted in organizing Investigator Meetings, Kick-off Meetings, study team teleconferences, and internal training.• Managed training of entry-level personnel.• Conducted Investigator Feasibilities and facilitated Confidentiality Disclosure Agreements.• Managed day-to-day record keeping for multiple trials using excel spreadsheets and Clinical Trial Management Systems (CTMS).

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, CRAs and Sponsors with study start-up, maintenance and close-out: collect regulatory documents (i.e. 1572s, financial disclosures, CVs, licenses, confidentiality agreements), maintain study files and database system programs (i.e. TrialWorks, Invivo, EDC, IVRS), and resolve outstanding issues in preparation for site close-out, final QC, and transfer or storage of physical files.-Assisted PM with QC review and managed TMF according to applicable SOPs.-Interact directly with multiple study vendors to order and distribute clinical supplies including, but not limited to CRFs, laboratory supplies, radiological review vendors, data management vendors, etc.- Assisted with the preparation of FDA-required regulatory submissions to CIRB and local IRB.- Assisted in the preparation of TMFs for archiving in accordance with sponsor SOPs.- Attended Investigator Meetings, Kick-Off Meetings, study team teleconferences, and provide project team support.-Managed record keeping of trials using excel spreadsheets and CTMS, i.e. TrialWorks.

• 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.• Working knowledge of MYSIS software applications, ICH/GCP, and biohazard certified.

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 government scientists.

Animal Science/Pre-Vet Med

Master’S Degree, Clinical Trial Management