Professional Services in Clinical Research (since
Employment Prior to PSCR
Freelance Clinical Research Specialist, Edinburgh, Scotland
I am a freelance clinical research specialist offering:
University spin out working in CNS
(Part of the Strategic Development Team and Head of the Clinical
Trial Management Team: April 2003 to date)
Pharma company developing products
based on their novel patented drug delivery technologies (Management
of the clinical project team and input to the clinical development
projects: July 2002 to date).
Herbal medicine/preparation company (Consultant advising on design and conduct of clinical
trials: May 2000 to date).
Biotech company (SOP preparation and
expert reviewer of documents: July 1999 to date)
CRO specialising in Health Economics
(Selection and management of staff and sites to conduct a large GP
observational trial in the UK: July 2002 to October 2003).
Device development company
(Co-ordination and management of trial critical for licensee
partners: February 2002 to January 2003).
Pharma company developing products
using novel patented drug delivery technologies (Selection of staff,
sites and co-ordination of sub-contractors for two trials; Staff
training: July 2001 to November 2002).
CRO (Staff recruitment and
management; project management of UK arm of trial: July 2001 to
CRO (Preparation of pre-trial
paperwork for multi-centre EU trial: February 2001 to date)
Biotech company developing products
for use in respiratory and g-i disorders (intellectual input; CRO
management; clinical project management: April 1997 to date)
Pharma company developing
radioisotopes and contrast media (monitoring: January 1997 to
advisor to project co-ordinator: Oct 97 to June 2001; CRO liaison for
statistical issues: July 99 to October 2000; project management May 2000 to
Specialist CRO (Assist with product
evaluation information: August 2000)
OTC healthcare company (monitoring: Q1-Q2 2000)
The Institute of Clinical Research
(Academic Liaison Officer: devised, validated and set up
post-graduate Clinical Research programme at Liverpool John Moores
University, including appointment and management of module leaders
and teaching staff: November 1996 to December 1999)
Contract Research Lab (GCP training:
August 1998 to March 1999 – 5 sessions)
Biotech company (writing – oncology
and inflammation: December 1996 to March 99)
Employment History prior to self-employment
Project Manager Medical Oncology: Oct 95 - Nov 96
Scotia Pharmaceuticals, Stirling
I reported to the Associate Medical sector.
- management of a programme of research trials designed to research the anti-cancer effects of Essential Fatty Acids, and achieve licences for the company’s products in this area;
- implementation of all new clinical trials;
- management of the department’s clinical trials budget (c£500 000 annually) and development of all financial agreements;
- preparation of clinical development plans, research protocols and final reports.
- management of two full-time, permanent graduate Clinical Research Associates who monitor the conduct of clinical trials to standards determined by me;
- development and training of these staff;
- assistance with strategy and planning of the development plans for Scotia’s principal forthcoming oncology product,;
- liaison and negotiation with oncologists and their research teams and hospital management in over 15 hospitals in the UK and Europe to develop research protocols, maintain confidentiality and ensure adequate protection of parties against litigation;
- liaison with pharmacists and laboratory management in the same hospitals in respect of finance and procedures;
- negotiation with printers and contract research organisations to ensure adequate support as required for the conduct of clinical research;
- organisation of drug supplies via accurate production forecasting and liaison with trial supplies department in the company;
In addition, I initiated changes impacting on the Medical Department as a whole:
- development of procedures to reduce individual trial monitors’ workload without compromising requirements of European laws and GCP guidelines;
- development of a quality assurance system across the various research teams to ensure similar high standards in all areas;
With another colleague, I devised a system for evaluating and managing the fluctuating resource requirements of the various research teams.
The role required extensive knowledge of European law and guidelines governing the conduct of clinical trials and the ability to manage and motivate large teams of people to ensure timely delivery of quality data. Within the company, the ability to negotiate effectively with other Departments, eg Statistics, Data Management, Production, Packaging etc was also essential. I was widely respected within the company for my experience and knowledge of trial requirements and practice and was frequently consulted by other experienced and inexperienced staff.
Project Manager Radiation Oncology: Nov 94 - Oct 95
Scotia Pharmaceuticals, Stirling
I reported to the Business Development Group Manager. Responsibilities included:
- management of a programme of clinical trials designed to achieve a product licence for an Essential Fatty Acid product that ameliorates the side effects of radiotherapy;
- planning future programme of trials for superior follow-up product;
- preparation of clinical protocols and reports on completed work;
- revision of Standard Operating Procedures to ensure trials across the various therapeutic areas were conducted to a uniformly high standard;
- many other activities similar to my current role but on a smaller scale;
Clinical Trials Manager: Apr 92 - Nov 94
Midlands Asthma & Allergy Research Association
Leicester General Hospital and Leicester Royal Infirmary
I worked alongside a Consultant Clinical Immunologist and reported to the Charity’s Executive Committee. Responsibilities included:
- day to day management of the Asthma and Allergy Research Units at both hospitals. This included the supervision and management of core staff: two permanent research nurses, one post-graduate research trials assistant, two administrative staff and one general ‘helper’;
- all negotiations with potential sponsor pharmaceutical companies to identify new business opportunities;
- ensuring the organisation could meet all commitments and see all projects through to timely and satisfactory conclusion;
- hiring, training where necessary, and managing all temporary medical, nursing and administrative staff (about 10-15 annually);
- management of all clinical trials to a quality I genuinely believe to be of the highest standard available worldwide. This included large scale (several hundred patients) and small scale (fewer than ten patients) trials in hay fever, perennial rhinitis, asthma and urticaria plus so-called challenge studies;
- widening of the organisation’s remit to include conduct and supervision of trials in General Practice and involvement in other areas related to clinical research;
- liaison and negotiation with all hospital staff (Chief Executive, Estates, Financial ector, Pharmacy etc) in relation to all trial and administrative matters. This included the negotiation of new premises;
- liaison with Trent Region’s legal department in respect of legal issues such as clinical trial indemnity;
- re-organisation, with the charity’s accountant, of the whole of MAARA’s financial administration, organisation and reporting to enable more sound money management. I registered the organisation for VAT, a major undertaking in view of several years’ back registration, and this provided a one-off windfall of over £30 000, with projected annual savings of about £7 000 net;
- In the two and a half years from my joining to my leaving I raised annual income from £200 000 to £350 000.
Clinical Research Associate: Jun 89 - Apr 92
I reported to the Clinical Research Manager for UK Operations. Responsibilities included:
- management of trial programmes for all UK Phase IV Phase IIIb (licence extensions) of anti-asthma drugs Tilade and Intal;
- budget management;
- management of several hospital centres for a trial of the critical care drug Dopacard;
- placement and management of bio-equivalence trials of generic compounds with Contract Research Organisations;
- management responsibility for two graduate Clinical Research Associates;
- preparation of clinical development plans;
- preparation of reports on clinical trials;
- preparation of Standard Operating Procedures;
- devising and implementing training for new and inexperienced Clinical Research Associates;
- assisting with presentation of clinical trial results to sales forces;
- winner of the Departmental ‘Initiative Quotient’ award in 1991;
This post was a watershed in my development. Circumstances were such that, within weeks of my starting, I was left to take on new and existing work in an area in which I had little relevant experience. Hard work, an ability to learn quickly and enthusiasm to do so were the principal factors that saw me through.
Clinical Research Associate: Aug 87 - Jun 89
The Boots Company Plc
Responsibilities included management of four small programmes of clinical trials of non-steroidal anti-inflammatory drugs and the writing of several research protocols and clinical reports.
Statistician: Oct 83 - Aug 87
The Boots Company Plc
Latterly, I was responsible for the supervision of a less experienced statistician in the analysis of clinical trials. My main duties, however, were responsibility for the design and supervision of the analysis of pre-clinical toxicity studies and design and analysis of animal pharmacology studies.
I twice won hard-to-come-by Merit awards at annual review for exceptional performance during my four years in post; one of only two staff to achieve such success.
I was considered by the Head of Statistics as especially good at Exploratory Data Analysis, identifying problems and suggesting innovative solutions and had an excellent rapport with ‘clients’.
Kolman J, Meng P, Scott G (Eds). Good Clinical Practice Standard Operating Procedures for Clinical Researchers.
John Wiley & Sons (1998)
Between 1986 and 1988, I published four papers on the work I conducted for my PhD thesis: three in the Journal of Soil Science and one in the Journal of Microscopy, which takes theoretical statistical articles. In 1988 I won the British Society of Soil Science Silver Jubilee Award for my pair of papers on ‘The Topology of Pore Structure in Cracking Clay’.
I am author of the chapter ‘Financial Implications’ in the
widely circulated Ethics Committee Working Group consultative document (1994)
Two articles on the role of the study site coordinator in Clinical Research Focus and various letters to the journal (1993-8). Several articles on the educational courses offered at Liverpool John Moores University (1997-9).
Stern MA, Dutthie M, Scott GJT, Podas T. A Pilot Study of Filtered Air Spectacles in the Prophylaxis of Seasonal Allergic Conjunctivitis. Presented as a poster at EACCI (1994).
Scott GJT, Goode K. Standardizing Ethics Committee Review.
Bulletin of Medical Ethics (1995)
Goode K, Scott GJT, Athey S. Contraceptive Precautions in Clinical Trials.
Bulletin of Medical Ethics (1996)
Scott G, Fitzpatrick S, George A.
Academic Qualifications in Clinical Research. Accepted by the International Quality Assurance Journal Nov 1999.
Acknowledgments for Statistical Assistance
Three refereed publications, one MD thesis, one MSc
dissertation, one BSc dissertation and one GP trainee project.