Experience

Regeneron

• United States
• Biotechnology
• 700 & Above Employee

• Sr Mgr Clinical Study Lead

  • Apr 2020 - Present

  Experience managing global insourced and outsourced, interventional (adaptive RCT) Phase 2-4 trials in Inflammation and Infectious Disease from start-up to closeout. Manage and oversee all CRA resource, onboarding, compliance, performance management and training across REGN COV aSPIKE mAB program. Experience managing global insourced and outsourced, interventional (adaptive RCT) Phase 2-4 trials in Inflammation and Infectious Disease from start-up to closeout. Manage and oversee all CRA resource, onboarding, compliance, performance management and training across REGN COV aSPIKE mAB program.



Amgen

• United States
• Biotechnology Research
• 700 & Above Employee

• Global Clinical Trial Manager

  • Jan 2012 - Apr 2020

  Manage global (including JAPAC region) interventional and observational Phase 2 - 4 trials inHematology/Oncology, Bone, Inflammation and Neuroscience. Experienced in insourced, outsourced and hybrid FSP models. Well versed in interventional, observational retrospective /prospective study designs, chart review, registry, PRO usability and validation studies. Contribute to Protocols, ICFs, Supply Chain Strategy, Budgets, Vendor SOW, Investigational Product Instructional Manual, Site Training, Monitoring Plans, eCRFs, Risk Assessment Plans, Data Element Planning, Recruitment / Retention materials and eTMF quality and timeliness. Manage Central and Specialty Labs, ETO, eCOA, ECG vendors, CROs and Adjudication committees for ONJ and Cardiac Safety. Oversight of Clinical Study Specialist and Regional Clinical Trial Mgr performance. Show less

• Feasibility, Patient Recruitment and Retention Manager

  • Nov 2005 - Dec 2011

  Inflammation, General Medicine and Neuroscience TA lead. Coordinate with Epidemiology tocreate landscape assessments for new indications. Develop TA/indication specific feasibility questionnaires to identify potential patients, barriers to recruitment, operational challenges & recruitment strategies. Analyze global feasibility data and provide recommendations for optimal geographical placement of study and potential barriers to recruitment and measures for mitigation. Advise study teams of optimal indication specific recruitment and retention vendors, develop study/site level recruitment templates, lead baseline/re-baseline enrollment forecasts in conjunction with global country operations team. Create novel weight-based algorithm to determine optimal country selection for Schizophrenia program. Lead SME to help design Amgen’s first in-house Enrollment Forecasting Tool, developed cost justification, aligning processes with data repository, develop UAT, LMS training, custom reports in conjunction with Planisware. Delivered ILT sessions in US, CAN and UK for all Amgen study teams. Show less



Prosum

• United States
• Staffing and Recruiting
• 1 - 100 Employee

• Feasibility Associate

  • Jul 2005 - Oct 2005

  Partner with internal Amgen study teams and CRO in execution of feasibility assessments. Partner with internal Amgen study teams and CRO in execution of feasibility assessments.



PHBS

• Reports Analyst

  • Jan 2004 - Jun 2005

  Responsible for reports, development of client specific custom queries, performance analysis, client data base set-up and management, physician credentialing and records management for physician claim processing. Created and Developed “Action Codes” which helped classify accurately follow-up activities. Responsible for reports, development of client specific custom queries, performance analysis, client data base set-up and management, physician credentialing and records management for physician claim processing. Created and Developed “Action Codes” which helped classify accurately follow-up activities.



Deloitte

• Business Consulting and Services
• 700 & Above Employee

• Senior Analyst

  • May 2000 - Aug 2003

  Consistent with client expectations & feedback, defined engagement strategy, objectives, scope & pricing, achieved accounts receivable of 9million, which was 1 million above the expected target. Co-ordinated with four hospital departments to obtain MRs and EOBs to help facilitate & expedite the billing and follow-up for claim resolution, the project team surpassed the set target of 1.5 million and delivered 3 million to the client, which resulted in a project extension and more “Accounts Receivable” for resolution. Created process flow charts for the UB / HCFA 1500 mailing process. Auditing claims and performing trend analysis. Created the “Project Set-Up Document”, which received the “Quality Award”. Show less