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Academic Background and Experience as Professional Medical Writer:
After graduating with a BSc in Biological Science and a BSc Honours and MSc in Medical and Veterinary Entomology, I started my career in the clinical trial industry in 2003 as medical writer for an international contract research organisation in Bloemfontein, South Africa, where I obtained intensive knowledge in the drafting of various types of medical writing documents, the design of Case Report Forms as well as gaining knowledge on the statistical and data management processes. My position as project manager of a group of Phase II-IV medical writers taught me valuable skills in team and client relationships.
Following my employment at the CRO I was appointment as project manager and contract medical writer for a well known clinical trial site in Bellville, South Africa of which I later became the general business manger. My duties included overseeing the financial, administrative, IT and data security, quality assurance, regulatory submissions and staff training aspects of the trial site while also performing project management and all medical writing activities. I was offered the opportunity to lead all project management activities and act as liaison for the trial site's affiliated data management company.
I have worked on Phase I to IV projects and have written, designed and reviewed numerous clinical trial protocols, trial reports, investigator brochures, patient informed consent documents, Case Report Forms & diary cards over a wide range of therapeutic areas. Many of these documents formed part of sponsor, GCP and in-house audits. I have also assisted in the writing and review of scientific papers and Standard Operating Procedures. I have compiled regulatory documents and overseen various clinical trial submissions to the Medicines Control Council and Pharma-Ethics in Pretoria, South Africa. As part of the protocol development process I have extensivley been involved in the clinical trial design of Phase I-III trials, including therapeutic and bioequivalence trials.
During my career as medical writer and business manager I have worked with various pharmaceutical companies, CROs, other trial sites and liaised on a regular basis with clinical trial investigators, nurses, data managers, data base programmers, data entry staff, statisticians, medical writers, project managers as well as medical advisors and representatives of Sponsor companies.
I decided to pursue my passion for medical writing and become an independent medical writer and in May 2010 I started my freelance business in Cape Town with the aim of providing cost-effective medical writing services to the clinical trial industry.
Today I feel comfortable to draft various clinical trial documents over a wide range of therapeutic areas. My research background and training enbables me to gain insight into and get up to speed quickly on therapeutic and drug development areas in which I haven't worked extensively. I regularly update my knowledge through intensive literature research and conferences.
My understanding of the clinical trial and data management processes enables me to work and interact confidently with various team players. I have a strong track record of client satisfaction and my clients have included both South African and international pharmaceutical companies as well as CROs, clinical trial sites and academic institutions.
Training Courses and Workshops Attended:
- Good Clinical Practice basic course and refresher course every 3 years at an accredited institution.
- In-house courses and workshops presented by Quintiles International:
- ICH GCP
- Overview of drug development and clinical trials
- HIPPA and European Clinical Trials Directive
- Project management
- Global customer focus
- Train the Trainer
- How to review an article
- Statistics workshop
- How to read and review a scientfic article
- Case Report Form design
- Writing of results in a study report
- QC review of a study report and appendices
- Introduction to laboratories
- Laboratory data in clinical trials
- Basic anatomy and physiology
- Pharmacokinetics
- Oncology and prostate cancer
- Drug-induced liver toxicity
- Calculation of bacteriological response
- Coding of adverse events and medical history
Conferences Attended:
- South African Clinical Research Association (SACRA) - Johannesburg, South Africa: 2008 to 2010
- European Respiratory Society (ERS) - Vienna, Austria: 2009
Affiliations:
- Member of the South African Clinical Research Association (SACRA): 2007 - current.
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