Carrer Sant Joan 31-4-10
Phone: +34 96 260 2344
Mobile: +34 618 482 173
An innovative and creative IT generalist and software designer with a scientific background and detailed knowledge of the processes of the discoveryand development of pharmaceuticals and agrochemicals. Fully conversant with all aspects of software development, from assessment of feasibility to audit against quality standards, and an effective team leader and technical project manager. Now seeking further opportunities to contribute to the technical development of novel informatics products or services, particularly in the pharmaceutical or agrochemical industry.
MAJOR STRENGTHS AND ACHIEVEMENTS
Technical project management and team leading
- Co-ordinated the technical efforts of an international and multidisciplinary team that developed a system which reduced the number of patients required in a clinical trial by 30% and reduced the duration of the trial. The statistical algorithms were developed by a team of experts in the US and integrated into a data capture and reporting system built by a software house in the UK. My role was to manage the contractual handover of the system and its documentation and its integration into several Pfizer deparments. The system collected data from investigator sites and returned in real-time an instruction to administer a randomised dose to patients and so was designed to comply with the FDA 21 CFR Part 11 regulation.
- Team lead for a project to implement an in-house developed clinical trials data management system into the office in Spain. Overcame many technical problems resulting from the system and database being managed in Australia by using Citrix. Played a key role in setting up the outsourcing of the on-going technical work to a company in India.
- Recruited, managed and led the team that delivered Pfizer’s electronic review aids and submissions for major new drugs that were judged by the regulatory agencies of the UK, Holland and Norway to have accelerated their review process.
- Managed external contractors building and implementing a system for the collection of data about clinical trials in the 4GL, Uniface, and later managed its migration to Visual Basic.
- Managed external contractors building and implementing intranet sites; one for the pharmacokinetics group involving technical data capture and presentation, and another for the clinical sciences department to facilitate intradepartmental communication.
- Managed internal staff and external contactors building a major intranet site that describes how the process of drug development was conducted at Pfizer. This web site was reported to be the most popular intranet site within the company world wide.
- Co-ordinator of the Professional Development Scheme of the British Computer Society.
Systems analysis and design
- Analysed the requirements for and designed the architecture of the system for conducting clinical trials described above that was built by a UK software house. The system involved data extraction from faxes, reporting to in-house clinical trial monitors and drug supply management and reporting for the pharmacy group.
- Designed the structure and the processes for building several versions of Pfizer’s electronic review aids for the regulatory submissions of new drugs.
Designed the architecture for the electonic clinical forms project described in the 'Software Development' section below.
Innovation and problem solving
- Implemented the first pilot document management system using Documentum in the company.
- Championed the idea and developed a method of keeping a project home page up-to-date without significant IT support in the days when web sites were developed by highly technical staff over many weeks or months.
- Introduced the 'project burndown chart' to the technical development team in order to meet the tight deadlines demanded for the migration of forms required for the electronic clinical forms project described below.
- Often invited to assist and investigate problems in projects outside my current assignments.
- Regularly conduct personal research and present interesting findings to the team and department about new tools and methods.
- Developed a major part of a system for automating the completion of the forms necessary for the start-up of clinical trials required by the external regulatory agencies and internal processes. The system was built in Livelink OScript, required a custom Oracle schema and used workflow to automate the review and authorisation processes of the forms. The system integrates to the company’s existing database of clinical trials and is used by CRAs throughout the world.
- Built several utilities in Excel and Perl to support internal review teams in accepting the clinical trials data capture and management system described above.
- Developed two versions of the project burndown chart, one in Excel and one in PHP/MySQL for helping teams deliver to tight deadlines.
- Built the first version of the PK data management system in Visual Basic and integrated to Lotus Notes and the global clinical trial database.
- Developed enhancements in Fortran to the company’s in-house system for the input and management of clinical trial patient data.
- Languages: Basic family (VB6, VBA, ASP), FORTRAN, C, Perl, PHP.
Databases: SQLServer, Oracle, MySQL.
Operating Systems: Windows, Linux, Unix, VAX VMS.
Methodologies: PRINCE, SSADM, UML.
Accent Business Communication: 2005 to present
Teacher of English and Writer near Valencia in Spain.
In company training courses and any writing assignments.
Eli Lilly Spain: 2003 to 2004
International project team lead.
Implementation of a fast clinical trials management system into the Spanish office.
Pfizer Global Research and Development: 1991 to 2003
Technical Assurance Consultant.
Information systems for clinical and regulatory departments.
Schering Agrochemicals Ltd: 1987-1990
Support manager for a validated toxicology data capture and reporting system under GLP, and for a Field Trials data capture and reporting system.
PHLS Centre for Applied Microbiology and Research: 1979 - 1987
Senior Administration Assistant. 1986 - 1987.
Analysis, design and development of systems for scientific staff.
Senior Microbiologist. 1979 - 1986.
Developmental research for Asparaginase (for leukaemia) and Human growth hormone production teams.
EDUCATION AND QUALIFICATIONS
BA (1973) converted to MA (1977) in Natural Sciences. Christ's College, University of Cambridge.
PhD (1975-1979) Welsh National School of Medicine, University of Wales.
Thesis title: Aspects of the Biochemistry of affective disorders.
Member of the British Computing Society (MBCS).
Chartered Engineer (CEng).
Member of the Biochemical Society.
Date of Birth: 1952; married; driving licence.
Languages: Spanish and French.
Interests: Learning and using new computer languages, running, walking, Tai Chi Chuan.