Experienced professional in the Health Care industry with over 25 years in Clinical Research. Versatile roles held include CRA, Project Manager, Functional Manager, and Department Head. Successfully supported clinical trials in diverse therapeutic areas, consistently meeting departmental and company Key Performance Indicators. Prioritized client deliverables and satisfaction through regular client meetings and feedback collaction.
Overview
32
32
years of professional experience
Work History
Senior Director of Clinical Operations ( Hub Lead)
ICON, formerly PRA Health Sciences
08.2016 - Current
Responsible for the Management of the Clinical Delivery team in Australia, New Zealand, India and South Korea
Sets overall direction, strategy and performance standards for multiple job disciplines to assure that project profitability targets are achieved
Ensures services provided to clients are compliant with PRA's policies, procedures, SOPs, ICH-GCPs, client contractual expectations and country specific regulatory requirements
Schedules and reviews project tasks to ensure high quality product is delivered on time and within the budget
Manages operational budget for the unit(s)
Mentors and develops employees to expand employee performance levels and assure retention of high performing PRA employees
Ensures appropriate employee resources are available to meet corporate/ client/ project objectives while achieving optimal billability of clinical operations staff
Development of Hubs in low cost centres including SMA, cCTM and CTM hubs.
Development of the Phase I and Paediatric networks across Australia.
Participant in bid defences and client feedback calls.
Member of quality review group involving review of audit reports across APAC.
Maintaining relationships across departments.
Director, Clinical Operations
ICON, formerly PRA Health Sciences
04.2007 - 08.2016
Function as legal representative for PRA in selected countries as appropriate
Provides input to central proposals for project bids to ensure all projects can and will be managed within contractually agreed upon schedules and budgets
Participates in client presentations and/ or bid defense meetings, as required
Provides guidance/ insight on aspects of clinical operations, as well as contingency planning, to accommodate project or therapeutic-specific nuances while identifying potential impacts of the same to budget
Establishes processes and participates in PRA's Quality Process Management continuous improvements by assuring that project quality metrics align with company, client and clinical operations objectives
Accurately projects resource needs to ensure timely hiring of clinical operations staff
Adjust resource allocation for project work as appropriate to ensure corporate billability targets are maintained while assuring client/ project objectives are achieved
Manager, Clinical Operations 2
ICON, formerly PRA Health Sciences
07.2005 - 04.2007
Manage and develop PRA employees to ensure high quality work performance and retention of high quality employees.
Communicates team and individual goals and expectations to ensure direct reports understand their responsibilities
Head of Strategic Development
Novotech (Aust) Ltd
09.2004 - 06.2005
Responsible for the development of strategies to enhance the success of Novotech's Clinical Trials. Inclusive but not limited to media coverage and advertising, in house marketing and training sessions. To promote recruitment on each study and working with sites and clients to enhance relationships.
Senior Project Manager
Novotech (Aust) Ltd
10.2002 - 09.2004
Responsible for leading team of cross functions to ensure all tasks were completed in a timely manner
Budget Management - responsible for project finance and budget
Responsible for ensuring project was correctly resourced.
Delivery of Project Deliverables on time and at high Quality
Project Manager
Novotech (Aust) Ltd
10.2001 - 10.2002
Effective management of Clinical Trial protocols inclusive of budget, deliverables, resourcing, client relationships
Senior Clinical Research Associate
Novotech (Aust) Ltd
01.2001 - 10.2001
Clinical Research Associate Co-ordinator
Orion Clinical Services Ltd
03.2000 - 11.2000
Lead CRA responsible for the oversight of project at a local level in addition to standard CRA activities.
APAC Clinical Trial Manager at ICON, Formerly PRA Health Sciences, Taipei, TaiwanAPAC Clinical Trial Manager at ICON, Formerly PRA Health Sciences, Taipei, Taiwan