...Professional Services in Clinical Research
...Independent Clinical Research Management

Dr Graeme Scott (2004)


Curriculum Vitae
Graeme JT Scott

 



Professional Services in Clinical Research (since Nov 96)

HyperlinksEducation      Employment Prior to PSCR    Other Related Interests  Publications     Qualities

Freelance Clinical Research Specialist, Edinburgh, Scotland

I am a freelance clinical research specialist offering:

  • Intellectual input to drug development programmes

  • Project management

  • CRO management

  • Site management

  • Monitoring

  • Document preparation and review (SOPs, protocols, Investigator Brochures)

    Clients to date

  • 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 December 2003).

  • 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 October 2000; 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 June 2001)

  • 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)

 


Education

University of Bath 1976 - 1980
BSc Statistics Class 1 Honours
Staff - Student Liaison Committee, University Colours Soccer 1st XI

University of Reading 1980 - 1983
PhD ‘An Analysis of Crack Pattern in Clay Soil’

University of Wales, Cardiff 1987 - 1989
Diploma in Clinical Science
Dissertation entitled ‘The Assessment of Subjective Measures in Clinical Trials’

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Employment History prior to self-employment

Project Manager Medical Oncology: Oct 95 - Nov 96
Scotia Pharmaceuticals, Stirling

I reported to the Associate Medical sector.
Responsibilities included:

  • 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
Fisons Plc

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’.

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Other Related Interests

Institute of Clinical Research


The Institute is the professional body representing scientists, nurses and administrators engaged in the design and conduct of clinical trials. There are over 4500 members.
  • Chairman of the Scottish Forum since October 2000
  • Having devised and implemented the Certificate in Clinical Research, the Post-Graduate Diploma and MSc, I am an honorary lecturer at Liverpool John Moores University and mark coursework (since 1998)
  • Member of Working Party developing Occupational Standards with ABPI (Nov 2000- Dec 2001)
  • Member of Accreditation Working Party May 2001 - May 2002
  • Academic Liaison Officer from November 1996 to December 1999. Successfully introduced the MSc in Clinical Research that started in January 1998 at Liverpool John Moores University.
  • Elected to Executive Committee in March 1993 and re-elected March 1995; stood down in March 1996.
  • Formed the Study Site Co-ordinator Sub-Committee in December 1993 and chaired it for 18 months;
  • Leader of the group that successfully negotiated with Liverpool John Moores University to introduce the Certificate in Clinical Research;
  • External course leader, past module leader and teacher on the course;
  • Organiser of several one day seminars; chairman or speaker on many occasions;
  • Introduced the one day training seminar ‘Introduction to Good Clinical Practice’ for research nurses, which currently runs up to four times a year;
  • Past trainer on the above course until 1999;
  • Co-ordinated response to Medicines Control Agency re: Ethics Committees;
  • past member of GCP and Ethics Forums (including steering committee of GCP Forum);
  • Honorary member of ICR since 1995.

Other Groups and Committees

    Secretary to the Leicester General Hospital Research Committee (April to Nov 1994).

    In January 1993 I helped form the Ethics Committee Working Group, a posse of individuals from industry, academia, ethics committees and the NHS. We set ourselves the task of reviewing and reporting on the problems facing Ethics Committees and those using their services. I wrote one chapter of the consultative document published in January 1994. Many of the recommendations have manifested themselves in the procedures adopted for the MREC system in the UK.



Other Lectures / Presentations

  • twice lectured on ‘The Analysis of Data and its Importance to Regulatory Evidence’ for Royal Pharmaceutical Society training courses (1989/90);
  • devised and ran a workshop on ‘The Use and Mis-Use of Statistics’ for the Diploma in Clinical Science’ at Cardiff;
  • lectured by invitation at annual meetings of two Contract Research Organisations (1993/94);
  • regular lecturer on ‘Statistics for Clinical Research Associates’ for ICR's ‘Introduction to Clinical Trials’ (1994/95);
  • workshop leader on protocol design for the same course (1994/95);
  • twice lectured by invitation at meetings of the Scottish Biomedical Association (1995/96).

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Publications

Book:
Kolman J, Meng P, Scott G (Eds). Good Clinical Practice Standard Operating Procedures for Clinical Researchers. John Wiley & Sons (1998)

Papers:
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.

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Personal Qualities

The ability to relate to all types of people, to motivate and lead and to communicate effectively, both orally and in writing.

I have an extensive network of contacts throughout industry and have found these to be of great help to many of my clients seeking advice.