Experience

Psychiatric Supportive Living
• United States
• Mental Health Care
• 1 - 100 Employee
• Psychiatric Asssistant

  • Apr 2023 - Present


AlphaSights

• United Kingdom
• Information Services
• 700 & Above Employee

• Executive Global Advisor

  • Nov 2021 - Present

  • Translate data into insights surfacing new understanding the way people think and behave • Partner with executives developing pragmatic strategies to guide their way forward during pandemic • Translate data into insights surfacing new understanding the way people think and behave • Partner with executives developing pragmatic strategies to guide their way forward during pandemic



Autism Learning Partners

• United States
• Individual and Family Services
• 700 & Above Employee

• Behavioral Health Technician

  • Dec 2022 - May 2023

  • Teach communication, social, self-help, and cooperative play skills through Applied Behavioral Analysis principles • Collect and record data on behavior, identifying and addressing problematic behaviors • Provide a safe and supportive environment • Maintain confidentiality of all clients • Teach communication, social, self-help, and cooperative play skills through Applied Behavioral Analysis principles • Collect and record data on behavior, identifying and addressing problematic behaviors • Provide a safe and supportive environment • Maintain confidentiality of all clients



Velocity Clinical Research, Inc.

• United States
• Biotechnology Research
• 400 - 500 Employee

• Associate Director Regulatory Affairs

  • Sep 2021 - Nov 2021

  • Script tested variety of electronic Regulatory platforms to ensure success initial submission, maintenance to closeout with real – time global visibility • Set expectations, and continuous alignment with digital regulatory vendors, IRBs, and internal stakeholders • Script tested variety of electronic Regulatory platforms to ensure success initial submission, maintenance to closeout with real – time global visibility • Set expectations, and continuous alignment with digital regulatory vendors, IRBs, and internal stakeholders



IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Sr. Manager, Clinical Site Budget SME

  • Oct 2019 - Aug 2021

  • Managed 25 key accounts across the E -Design & Planning suite for clinical trials • Strategized with clients ensuring client specific UI requests were relayed to product owner in a clear manner minimalizing misinterpretation / delays • Lead product development, testing and implementation, ensuring client’s expectations were exceeded • Reported and identified market trends developing new program concepts during pandemic • Collaborated cross-functionally with key stakeholders to align on strategic initiatives • Partnered with domestic and international ethics agencies ringfencing institutional and site cost during pandemic • Recruited, interviewed, and mentored customer success managers, subject matter experts, and consultative services team Show less



UCB

• Apparel & Fashion
• 1 - 100 Employee

• Contract Manager

  • Aug 2014 - Oct 2019

  • Managed General Data Protection Regulations (GDPR) terms and conditions for European Economic Area and Non–EEA agreements for 300+ templates including CTAs, Non-Interventional Study Agreements (NISA) and MCTA Work Orders; required translation to over 20 languages • Served as primary liaison between General Counsel and top-tier institutions • Facilitated negotiations of Global Master Clinical Trial Agreements (MCTAs) finalizing over 350 globally • Forecasted site budgets for 58+ countries, averaging 120 adjustments annually in GrantPlan • Provided expert level budgetary support to facilitate optimum cost-per-study participant • Fostered relationships with Clinical Project Management, Compliance and IP Legal • Annually updated Budget and Legal playbooks for CRO partners • Sunshine Act and Anti–Kickback Statute Subject Matter Expert • Managed contractual tax endeavor/multiparty transition during CIA Show less



inVentiv Health

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Grants Manager (consultant) for Biogen, Shire and GSK

  • Oct 2009 - Oct 2012

  • Facilitated negotiations of Investigator Confidentiality Agreements, Letters of Intent, Consulting Agreements, Master Services Agreements, Individual Project Agreements, and budgets • Liaised with various internal and external groups including strategic partners, regulatory bodies, and subject matter experts to maintain a high level of quality and consistency across clinical programs • Analyzed and interpreted data for current enrollment, study status and costs • Facilitated negotiations of Investigator Confidentiality Agreements, Letters of Intent, Consulting Agreements, Master Services Agreements, Individual Project Agreements, and budgets • Liaised with various internal and external groups including strategic partners, regulatory bodies, and subject matter experts to maintain a high level of quality and consistency across clinical programs • Analyzed and interpreted data for current enrollment, study status and costs

• Lead (Study Start Up)

  • Oct 2007 - Apr 2009

  • Managed client’s timelines guaranteeing in accordance with contractual requirements and expectations; ensured adherence to SOPs and appropriate regulations • Monitored and managed staff workload to optimize resource utilization • Reduced First-Site-Initiated timelines through consistent per-patient budget/contracting process improvement • Managed client’s timelines guaranteeing in accordance with contractual requirements and expectations; ensured adherence to SOPs and appropriate regulations • Monitored and managed staff workload to optimize resource utilization • Reduced First-Site-Initiated timelines through consistent per-patient budget/contracting process improvement



PPD

• United States
• Research Services
• 700 & Above Employee

• Senior Specialist

  • Apr 2007 - Oct 2007

  • Conducted investigator file audits • Ensured accurate completion and maintenance of internal tracking systems, timelines, and project plans • Conducted investigator file audits • Ensured accurate completion and maintenance of internal tracking systems, timelines, and project plans



Constellas

• Technology, Information and Internet

• Clinical Operations Specialist

  • Dec 2004 - Apr 2007

  • Monitored and managed site study files traveling 75% • Drafted Site Reports post monitoring trips and proactively flagged queries • Monitored and managed site study files traveling 75% • Drafted Site Reports post monitoring trips and proactively flagged queries