Delivery-focused professional with over 24 years of experience in clinical research, including 12 years in project management.
Overview
27
27
years of professional experience
Work History
Associate Director Global Trial Lead
Bristol-Myers Squibb
Irvine
11.2021 - Current
Provided strategic and operational leadership for global Phase 1-3 trials.
Implemented operational efficiencies in clinical trial management processes.
Led cross-functional teams, overseeing performance and quality of the CRO partners.
Drove collaboration among stakeholders for efficient trial operational delivery.
Monitored study budgets, forecasting, planning and reporting activities.
Senior Project Manager
ICON Clinical Research
Irvine
01.2013 - Current
Act as the operational lead in the day-to-day management of full-service, international programs of clinical trials; serve as the primary operational contact for the study; manage all vendors and functional leads; anticipate and manage risks and issues; ensure compliance with the SOPs, study contract, and international regulatory requirements.
Support design, oversee implementation, delivery and reporting of projects; develop cross-functional plans, budgets and resources planning, risk assessment and contingency planning.
Accountable for time, cost and quality targets as well as resource and budgetary control throughout the life of the projects.
Project Manager
PRA International
Mannheim
01.2012 - 12.2012
Managed the execution of large multi-countries projects from protocol feasibility to close out.
Ensured quality deliverables, on-time and within budget.
Provided leadership and guidance to a team of functional leads regarding all aspects of clinical trial operations. Manage all vendors and functional leads.
Project Manager
PAREXEL International
Langen
03.2010 - 12.2011
Responsible for management of global clinical trials including complex study budget management, financial tracking and control.
Interact with client and team leadership to ensure that the projects proceeds on time and within budget. Ensures study adherence to ICH/GCP and SOPs.
Participate in proposal development teams; provide input to particular indication and operational structure.
Plan and schedule activities and deliverables through all stages of clinical studies and programs, plan and manage resources for multi-functional matrix study teams to achieve team delivery against commitments and goals.
Global Research Operations Lead
PAREXEL International
Bucharest
12.2004 - 03.2010
Promoted from CRA to Clinical Lead then to Global Research Operations Lead.
Provided leadership and guidance to a team of CRAs internationally regarding all aspects of clinical trial operations.
Proved record of exceeding timelines, holding the team accountable for metrics and deliverable, developing relationship with clients and increasing business portfolio.
CRA
Cardiomed CRO
Bucharest
10.2001 - 12.2004
Responsible for monitoring regional Phase II, III and IV clinical trials in accordance with the ICH-GCP Guidelines, SOPs and monitoring guidelines, in roles of increased responsibilities.
Medical Representative
Merck Sharp & Dohme
Bucharest
03.2001 - 09.2001
Responsible for promoting company drug products and communication with clinical opinion leaders, attendance of appropriate scientific meetings to maintain awareness of research activities in the company products area of expertise, building trusting relationships with customers by partnering with them to develop relevant solutions through disease outcomes and education of pharmaceutical portfolio.
General Practitioner
Sf.Maria Clinical Hospital
Bucharest
01.1999 - 03.2000
Clinical Experience in one of the largest clinical hospitals in Bucharest, Romania.
SENIOR GLOBAL TRIAL SPECIALIST, GLOBAL TRIAL MANAGEMENT at Bristol Myers SquibbSENIOR GLOBAL TRIAL SPECIALIST, GLOBAL TRIAL MANAGEMENT at Bristol Myers Squibb