Greater Toronto Area, Canada
Enthusiastic professional with clinical operations experience. A role fluidity advocate with customer centricity who drives elements of creativity, efficiency and effectiveness into both routine and complicated tasks. Extensive experience in problem solving. Adept at overseeing daily clinical operations and creating relationships between the local study teams and clinical sites. Skilled as a finance resource to support contract negotiation and budgeting.
• Lead, manage, and oversee GI/GU oncology clinical trial studies stages from feasibility, start-up, maintenance and close out according to Roche study standards. o Global responsibilities include: Study level objective/endpoint planning (interim analysis/recurrence free status) and multi-countries management and oversights, leadership in the working group (protocol amendments, layperson summary, etc.) and collaborations with various functions (Safety, Science, Regulatory, etc.) to ensure timelines are met and milestones are achieved. Vendor management (Labcorp)/study sample management (SDCRe); perform vendor budget and invoices review, and conduct year end vendor expenses accrual assessment. o Canada country responsibilities include: Lead country and site feasibility on new GI/GU oncology studies and conduct country and site feasibilities with potential PIs; site start up preparation, PAV/SIV, and activation; site budget negotiation; local study documents implementations. Country and site level day-to-day operation, Health Canada and local REB regulatory documents reviews and submissions, site monitoring and issues management and resolutions, country lead for Roche internal study ICF audit. • Conduct periodic global operations and local study team/monitor calls. Oversee communications with countries, monitors, and sites to ensure information is disseminated in a timely manner.
• Lead, manage, and oversee GI/GU oncology clinical trial studies according to global standards. Duties include site-level protocol/amendment preparations and implementations, day-to-day operation activities, regulatory documents reviews and submissions, site monitoring reports review, site issues management, etc. • Assist Country Study Manager in study start up activities including new study site activation preparation, contract and budget negotiation, site system set-up and presented at the site pre-activation visits (PAVs). • Support and collaborate with Global Study Managers, Country Study Managers, and study monitors to ensure studies/sites issues and queries are promptly addressed and resolved. Provide guidance to study monitors on site related matters, conduct periodic LST/monitor calls, and oversee site level related communication. • Perform periodic quality review of country-level Trial Master File per GCP regulations and internal guidelines. Prepared country-level readiness (i.e. TMF Health Check) for health authority inspection (i.e. MHRA). • Provide approval and guidance to the finance team on study visits/procedures verification.
• Lead and manage IxRS system development for clinical trial studies in oncology through the collaborations with the global study team and 3rd party vendor (i.e. Signant Health and Almac). • Liaise between global study managers, data managers, biostatisticians and 3rd party vendors to ensure IxRS system specifications are met as per protocol requirements. Additional duties include create and review of user datasets (UDs) and conduct user acceptance testing (UATs) prior to the system go live.
• Served as key financial personnel in clinical trial contract review and provided support to business development group, contract management team, and portfolio/project management teams during the contract negotiation process. • Researched and resolved complex clinical trial project related financial issues. Recommended actions to address variances to project team and the senior management. • Developed and finalized financial metrics. Provided financial analysis on actual/forecasts vs. budget on professional fees and pass through expenses; closely monitored the overall project financial performance.
• Perform day-to-day accounting operations including month/period-end close, account reconciliations, financial reporting, and key accounts monitoring and validating. • Conduct account analyses and prepare financial reports in supporting management team decision-making. • Evaluate organizational structures and determine appropriate accounting methodology to ensure smooth field-accounting functions integration and corporate-field transition. • Liaise between the corporate and field business managers and coordinate intra-company month-end closing activities in compliance with closing timeline and corporate/shared service center accounting policies. • Participate in internal Sarbanes Oxley testing; assist in field office standalone and the corporate 3rd party (D&T) external audits. • Research and resolve complex accounting issues; develop, review and implement standard accounting procedures/reporting processes in the areas needed improvement. • Build and maintain MS ACCESS and QuickBooks databases; set up query functions for both internal and external audits. • Train and mentor colleagues.
• Prepared accurate and complete financial statements and month-end closing reports in a timely fashion. • Performed A/P, A/R, bank reconciliation, bookkeeping, and general ledgers balance. • Analyzed and forecasted budgets based on financial measurements on departmental costs, expenses, and revenues; recommended appropriate budget level and expenditure control to the senior management. • Conducted breakeven analysis to assess the feasibility of new services and required logistics. • Developed and maintained Quickbooks accounting/financial database; establish business documentation filing systems. • Initiated and recommended processes to resolve accounting discrepancies or institute new accounting practices. • Coordinated inter-departmental activities; liaised between accounting auditors, government agencies, and clients. • Conduced contract and lease negotiations and vendor selections. • Autonomously managed office operations in the areas including HR, logistics, purchasing, IT, etc.
• Conducted P&L performance, financial statement analyses, cost structures, and what-if profit analyses in supporting 15+ acquisition pitches for prospective dialysis facility and de novos and acquisitions. • Developed financial models to forecast financial performance for prospective deals. • Created and maintained 5+ end stage renal disease (ESRD) MS Access databases for supporting business development and future market presence and assisted senior management in PowerPoint presentation. • Conducting 20+ thorough market researches and analyses in supporting the Business Development Department’s decisions on expanding RRC’s dialysis market presence and patient population.
• Designed and conduct formulation development studies for prospective drug candidate. • Key formulation team member of the Genentech/Altus Alliance Project.