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About me

Over the years I have had various work experience from security (for companies such as Sony, Thames Water and the Middle East Broadcasting Company) to servicing Sea King helicopters and the ageing Boeing 707s.

Clinical Data Management is what I’ve been involved with for over 4 years now (Here’s a copy of my CV) having worked on a number of drugs including the first billion dollar drug, Viagra, and various life saving cardiovascular, diabetes, oncology and anti-fungal therapies. But what does a clinical data manager do? That's what most people ask me when I tell them what I do! So here's a short description!

The role of the clinical data manager:
A clinical data manager is responsible for coordinating and monitoring the flow of clinical data into the computer database. He or she analyzes and evaluates clinical data, recognizes inconsistencies, and initiates the resolution of data problems. He or she implements data management plans designed to meet project and protocol deadlines, and consults in the design and development of clinical trials, protocols, and case report forms. A data manager also acts as liaison between clinical management and subcommittees and project teams on an as-needed basis. Data Managements’ main function is to ensure the clinical trial data is of high quality and integrity. A typical department consists of statisticians, data coordinator,s data entry staff (unless EDC is being used) and team leaders. Data managers need to be able to get on with a variety of people!

Steps involved in the data management process typically include:    A review of the clinical information prior to data entry

  •     The design of the Case Record Form (CRF)
  •     Entry screen development and database design
  •     Data entry (completed by data entry staff or by the clinic staff, not by myself!) and verification
  •     Visual audits
  •     Coding of drugs, conditions and adverse experiences
  •     Creation, programming, testing and execution of computerized validations
  •     Validating data, generating queries which are then sent out to participating research centres
  •     Quality assurance audit
  •     Final database releases in SAS Dataset or ASCII file formats ready for statistical analysis and report writing.

Nowadays most of the work is outsourced/off-shored so the role of the data manager/project manager is to oversee this work.

If you have any queries, let me know! There's a very interesting article on the need for pharmaceuticals to revolutionise their data management systems: "Clinical trial data management - tortured by paper"

For more info on contracting in the pharma industry, please see the following sites:

www.pharmiweb.co.uk

www.inpharm.com

www.meijboomconsulting.co.uk - that's how I operate, preferably direct with the clients rather than middle-man agencies.

 


Environmental Management has always been an interest of mine, but so far have not been given that *break* by potential employers (apart from a brief stint in the Cartographical Dept at the NSW Minerals). I’ve completed one degree in GIS (Geographical Information Systems) and another in Rural Resources and Environmental Policy. Ideally I want to combine the two in a job which is both varied and interesting and preferably involves some outdoor work (whether it’s ‘ground-truthing’ remotely sensed data or taking GPS coordinates I don’t care) as sitting behind some radiation leaking CRT screen is no fun until you retire! With strong interests in environmental management coupled with new technologies and with two degrees in this field I would relish employment in this area. Having experienced various types of environments in Africa, Asia, the Americas, the Middle East and Europe I have become very aware of environmental degradation and the need therefore for effective policy making.  With a vegetarian lifestyle from a young age and through my involvement in various organisations such as Greenpeace and the WWF, I have become even more determined to commit my future career to conservation and the environment.  Ultimately I see myself gaining a position where I am planning, managing and co-ordinating effective environmental programmes in order to reduce Man's impact upon the environment.

Having undertaken a BSc in Geographical Information Systems (GIS) I realise the potential that modern technology can offer the environment.  Not only can the environment be visualised in multitude of mediums but the emerging technologies can also undertake 'what if' scenarios before policies can be formulated.  Much of this spatial technology is now built into your various mediums such as satnavs, google maps, phone apps etc. Thus, having gained the technical expertise, I went on to undertake a MSc in Rural Resources and Environmental Management (Imperial) where I acquired a broader understanding of our complex environment.  Involvement in various schemes such as the Kentish Stour Countryside Project has illustrated the difficulties of effective environmental management, I believe that I have the necessary determination to do so. Potential employers can read my CV here.

"A man is a success if he gets up in the morning and goes to bed at night, and in between does what he wants to do" Thomas Jefferson

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