Insurance Manager of Account Review - Global Life Insurance - Edison
(2023-11)
- Formulated marketing strategies and managed accounting functions, including audit, bookkeeping, sales campaigns, promotions, and networking.
- Executed sales brochures, payroll, and order guides, while also providing training, education, and sales presentations.
- Conducted business analysis by evaluating company resources, capabilities, and competitiveness.
- Assessed company strengths and weaknesses against market opportunities and external threats to devise innovative strategies for business improvement.
- Developed PowerPoint presentations, bid defenses, workshops, and manuscripts.
- Orchestrated multiple projects simultaneously and maintained current operational and logistic contracts.
- Partnered with internal and external stakeholders to organize and execute diverse projects.
- Spearheaded the promotion, coordination, and development of sales initiatives.
- Reviewed requisitions, change orders, reimbursements, expense reports, and other financial transactions related to projects.
- Created training and educational materials, including presentations for seminars and other activities.
- Maintained comprehensive records, compiled and monitored the master schedule for meetings and sales applications, and developed budgets.
Clinical Research Manager - Hackensack University Medical Center, Hackensack Meridian Health Network - Hackensack
(2019-03 - 2023-04)
- Directed the master schedule for multiple clinical trials, encompassing infectious diseases (COVID-19) vaccine studies and oncology, while cultivating relationships with a diverse range of vendors, healthcare providers, and suppliers for general health, pain management clinics, and hospitals.
- Supervised Contract Research Organizations (CROs) in task execution and deliverable development, including protocols, databases, monitoring plans, statistical analysis plans, informed consent templates, deviation and evaluability plans, recruitment strategies, data review plans, and team communication plans, ensuring site qualification, initiation, interim monitoring, and close-out.
- Collected and curated data from multiple sources, including electronic notebooks, spreadsheets, slide decks, and instrument files.
- Validated data quality, consistency, and completeness across disparate datasets.
- Implemented data standards, ontologies, and metadata to streamline data integration and analysis.
- Facilitated data discovery, access, and sharing throughout the organization.
- Collaborated with scientists and engineers to identify data sources, understand data requirements, and implement effective data solutions.
- Conducted remote and on-site data reviews for completeness, clarity, legibility, and conformity to source documentation, adhering to specific regulations.
- Resolved queries with study sites, identified clinical data trends, and escalated pertinent issues to medical monitors, maintaining clear communication with sites and providing study training.
- Assisted in planning, budget preparation, clinical site selection, initiation, monitoring, and close-out visits.
- Ensured the quality and integrity of site practices in compliance with GCP/ICHs guidelines, including writing, reviewing, and adjudicating cross-functional comments to uphold high clinical quality in collaboration with medical writing teams.
- Oversaw study procedures, safety assessments, Serious Adverse Event (SAE) and Adverse Event (AE) reporting, Informed Consent Form (ICF) preparation, Case Report Form (CRF) design, and maintenance of source documents.
- Authored memos and intervention plans to prevent redundant errors and protocol deviations.
- Prevented significant protocol deviations through meticulous review and analysis of protocol amendments, coupled with clear communications with Sponsors, CTMs, and CRAs.
- Managed study procedures, safety assessments, SAE/AE reporting, ICF preparation, CRF design, and source document maintenance for various studies in anticipation of internal/external audits.
Patient Care Management (Nursing) - Hackensack University Medical Center - Hackensack
(2010-04 - 2019-01)
- Effectively led cross-functional teams, ensuring high-quality execution of clinical trial procedures, with a strong understanding of investigational products and devices.
- Coordinated with clinical staff, including nurses, data coordinators, laboratory technicians, and other clinical trial support personnel, ensuring adherence to assigned tasks and making operational decisions regarding staffing levels and workflow.
- Maintained optimal staffing levels on clinical trials to meet study protocol and budget requirements, in accordance with department SOPs, ensuring cost-effective resource utilization.
- Re-allocated staff as necessary to ensure daily workload completion and developed improvement plans based on collaborative data analysis.
- Ensured strict compliance with protocols, SOPs, and all applicable guidelines, playing a key role in helping sites meet study milestones, including data submission timelines for database lock.
- Collected data, assisted with site report reviews, and monitored regulatory documents from study start-up through close-out.
- Diligently protected subject confidentiality and reviewed factors potentially affecting subject safety and clinical data integrity at investigator sites, such as protocol deviations and pharmacovigilance issues.
- Addressed queries promptly, participated in global clinical monitoring/project staff meetings, and attended project-specific clinical training sessions.
- Implemented site close-out activities and generated comprehensive site close-out reports.
- Provided performance feedback on sites to inform future trial site feasibility and selection.
- Reviewed monitoring reports, data collection, entry, and cleaning processes to guarantee accuracy.
- Verified site compliance with protocols, SOPs, GCP, and FDA regulatory requirements, managed core laboratories, and organized investigator meetings.
- Assisted with source document, eCRF, ICF, and subject file review and management.
Administrative Assistant - Sanofi Global Biopharmaceutical - Belgium, Belgium
(2008-07 - 2010-03)
Focused on creating a consistent and positive customer and team experience.
- Assisted in supervising and overseeing all team members and business operations, monitoring and facilitating production processes, data entry, and quality control.
- Managed office organization by maintaining supplies, equipment, and overall order, while scheduling meetings, appointments, and travel for executives and team members.
- Handled incoming calls, emails, and other inquiries, directing them appropriately.
- Coordinated office events, meetings, and conferences.
- Facilitated onboarding training for new team members and provided training and development support, monitoring goals and offering feedback.
- Took immediate action on pertinent matters while adhering to company policies, assisting managers and team members with goals and assignments.
- Performed various administrative duties including scheduling, payroll management, training compliance, bidding, supply ordering and receiving, and inventory control.
- Coached, counseled, and provided feedback to team members on performance to ensure adherence to company policies and standards.
- Maintained communication with the Lead Consultant and production team to ensure deadline adherence and quality checks.
- Communicated daily/weekly/monthly goals, performance metrics, customer issues, and company initiatives to management and team members.
- Supported daily operations by performing diverse administrative, clerical, and office management tasks.
- Applied organizational, communication, and multitasking abilities to ensure smooth office operations and effective coordination between departments, staff, and external stakeholders.
- Drafted, proofread, and prepared correspondence, reports, and other documents.
- Maintained and updated both physical and digital filing systems.
- Prepared presentations and materials for meetings.
- Ensured secure storage and management of documents and confidential information.
- Assisted with budget tracking, invoice processing, and expense reporting.
- Prepared and submitted purchase orders, tracked orders, and managed office supply inventory.
- Supported payroll, HR, and employee benefits tasks as applicable.
- Entered and updated data in spreadsheets, databases, and other systems.
- Generated reports, tracked key performance indicators (KPIs), and assisted with administrative data analysis.
