

A seasoned, team-oriented AD who has demonstrated innovation, financial acumen, and general management competencies with a highly successful track record in clinical trial management. More than 20 years progressive experience in the Clinical Research and pharmaceutical industry. Experienced in crafting strategies in a highly complex project environment to meet bottom line targets, including training, and retaining resources to support the vision and achieve project targets. I have experience working with Pharmaceutical companies and small biotech companies. Achieved client satisfaction survey scores averaging 8.3 out of 10 in the past. Resulting to a few “no-compete projects” being awarded due to excellent client relationship and satisfaction.
Clinical Therapeutic Areas include:
· Operational lead in the day-to-day management of full-service global studies.
· Responsible for overseeing implementation, delivery and reporting of projects.
· Accountable for time, cost and quality targets as well as resource and budgetary control throughout the life of the project.
· Responsible for managing/coordinating and directing cross-functional task leaders from all contracted services within Vertex both locally and internationally.
· Responsible for oversight of contracted third party vendors.
· Responsible for identifying, anticipating and managing risks and issues. . Responsible for ensuring compliance with PPD SOPs, staff training,
study contract and international regulatory requirements
. Responsible for managing resourcing to meet project needs and
ensuring budget allocation are within budget scope.
. Responsible for analyzing, maintaining project performance metrics to
ensure optimum performance and client delivery satisfaction.
. Responsible for managing and contracting external vendors.
· Operational lead in the day-to-day management of full-service global studies.
· Responsible for overseeing implementation, delivery and reporting of projects.
· Accountable for time, cost and quality targets as well as resource and budgetary control throughout the life of the project.
· Responsible for managing/coordinating and directing cross-functional task leaders from all contracted services within Vertex both locally and internationally.
· Responsible for oversight of contracted third party vendors.
· Responsible for identifying, anticipating and managing risks and issues. Responsible for ensuring compliance with Vertex SOPs, staff training, study contract and international regulatory
requirements
· Operational lead in the day-to-day management of full-service global studies.
· Responsible for overseeing implementation, delivery and reporting of projects.
· Accountable for time, cost and quality targets as well as resource and budgetary control throughout the life of the project.
· Responsible for managing/coordinating and directing cross-functional task leaders from all contracted services within PAREXEL both locally and internationally.
· Responsible for oversight of contracted third party vendors.
· Primary contact point for sponsors and internal PAREXEL management during the project.
· Responsible for identifying, anticipating and managing risks and issues. Responsible for ensuring
compliance with PAREXEL and Sponsor SOPs, staff training, study contract and international regulatory
requirements
· Plan and schedule activities and deliverables
· Plan and manage resources
· Manage clinical trials including study budget management, financial tracking and control
· Interact with client and team leadership to ensure that the projects proceed on time and within budget
· Operational lead in the day-to-day management of full-service global studies.
· Responsible for overseeing implementation, delivery and reporting of projects.
· Accountable for time, cost and quality targets as well as resource and budgetary control throughout the life of the project.
· Responsible for managing/coordinating and directing cross-functional task leaders from all contracted services within ICON both locally and internationally.
· Responsible for oversight of contracted third party vendors.
· Primary contact point for sponsors and internal ICON management during the project.
· Responsible for identifying, anticipating and managing risks and issues. Responsible for ensuring compliance with ICON SOPs, staff training, study contract and international regulatory requirements
· Responsible for the management of a portfolio of clinical and academic trials in Asthma, COPD and allergy. My main projects included a COPD project with Astra Zeneca and an academic COPD study on Proteomics and Genomics funded by the NIH.
· My responsibilities included management of the academic clinical lab technicians and close collaboration
with scientist and research fellow.
· Involvement in the management and negotiation of clinical trials being outsourced to the Wellcome Trust Clinical Research Facility in Southampton and other vendors such as Pulmonary Function testing, MRI and CXR.
· During this period, I was also involved in Asthma and Allergy Clinical trials ranging from Phase 1 to Phase II involving Investigational inhalation drugs and subcutaneous treatment for allergy (Immunotherapy).
Key skills
Project and Programme Management
Strategy Planning
Leadership and Team Building
Client Management
Budget Management
Risk Management
Global and strategic sourcing
Contract review
Quality management, compliance and maintenance
Vendor management
Multi-Functional Leads/operational management
KPI review and management
Training compliance and process improvement
Detail orientated
Clear and consice communication