Roger Tun Email & Phone Number

New York, Ny, Us

New York City Metropolitan Area

I help Beaufort clients accelerate their path to market by outsourcing their trials and clinical work to our world-class team. In addition, I build relationships with a range of industry partners to expand our company's services.Beaufort is a global CRO built around one purpose — helping life science companies improve and save lives through the rapid development and commercialization of innovative products. Our shared interest and commitment to your success drive our entire organization to deliver best-in-class clinical trial services, regulatory strategy and planning, data and business analytics, data management and statistics, and quality services

New York City Metropolitan Area

I developed and implemented Real World Evidence and patient clinical outcome studies for Type II diabetic and early-stage chronic kidney disease patients (CKD 1-3) with numerous large health systems (Mount Sinai, Wake Forest, Atrium Health, and University of Utah).In addition, I:· Collaborated with hospital Population Health leaders to develop integrated care models with supported care navigation for early-stage CKD/ DKD patients.· Accomplished full test ordering integration with EPIC (EHR) to minimize barrier of test adoption and enhance clinical and health economic data collection.· Identified and communicated clinical development risks and mitigation strategies with executive leadership team.· Reviewed and executed Clinical Trial Agreements, negotiated budgets, statement of works with health systems and vendors.· Performed ongoing vendor management and oversight of all company studies, including review of performed work against budget, negotiation of scope of work, change orders and budget amendments, performance management and issue resolution in close collaboration with program leaders and Chief Medical Officer.· Worked closely with healthy system Principal Investigators to ensure timely and appropriate processes for obtaining, and shipping bio-samples to ensure integrity for analysis and data generation.· Ensured appropriate reporting, documentation, completion, and finalization of any corrective and preventive actions (CAPA) plans resulting from site audits and inspections.

New York City Metropolitan Area

I led the design of clinical projects, including developing trial protocols and budgets, CRO/ vendor selection, investigator/ site selection, data collection and analysis plans, and publication strategies.In addition, I:· Managed day to day clinical operations complying with ICH/GCP and ISO 14155 standards.· Developed operational project plans with timelines and company deliverables, overseeing budgets and schedules.· Tracked and managed project resources and contributed to contingency planning for key resources.· Managed site identification, review of monitoring reports, and conducted periodic review of clinical data completion.· Developed and implemented study Trial Master File (TMF) and oversaw periodic maintenance and reconciliation of TMF with site investigator file by CRAs.· Managed review and approval of protocols, SOPs, and study-related documents (e.g., Regulatory Binder, Work Instructions, CRF Completion Guidelines, etc.).

In collaboration with the Project Director, I defined, developed, and set project timelines, budgets, necessary procedures, staffing requirements, and resources in various phases of projects.I also:• Directed and coordinated the staff and activities to ensure goals and objectives were accomplished within projected timeframes and budget requirements.• Reviewed status reports and modified project schedules and/or plans as required.• Prepared and presented project reports for management, clients, or others.• Conducted clinical protocol training and Standard Operating Procedure (SOP) training.• Performed monitoring visits as needed (e.g. Quality assurance, SWOT, interim monitoring visits, etc.).

In this role, I was assigned to multiple clinical trials. I participated in study-specific training and conducted on-site monitoring visits (SQVs, SIVs, IMVs, and COVs). I participated in project scoping teleconferences and meetings as part of the Beaufort Operations team. I also assisted with budget preparation and proposals and attended meetings and conferences.