Highlights:Programme Manager for a pilot phase Cryptococcal Screening Programme on behalf of the Department of Health; Local study manager for the 1st real world evidence study at my current affiliate in South Africa

Skills:Epidemiology, Medical Affairs, Real world evidence, Clinical Project Manager, Clinical Research

Goal:Being a pivotal member of a medical affairs or clinical research team, within a pharmaceutical/biotechnology firm or academic setting (hospital).

Certification:Good Clinical Practice (GCP), CRA Training Course, MS Project Basic 2016, Monitoring and Evaluation of Health Programmes

Honor:US CDC bursary for MPH (Field Epidemiology) studies; Cum laude graduate for a Pharmatrain accredited Postgraduate Diploma in Medicine Development Regional award "Best Clinical Practice" for role as real world evidence study management and implementation in local affiliate

Medical Science Liaison/Local Study Manager 09/2016 - current
Novo Nordisk, Sandton, Gauteng South Africa
Industry: Pharmaceutical
I am currently a medical science liaison and local study manager (real world evidence study) for the Diabetes and Obesity therapeutic areas.
• Develop professional relationships with Key Opinion Leaders (KOL’s) and other external stakeholders (identify and support study sites, institutional support, speakers and Advisory Boards) as well as internal stakeholders (training, scientific support to Regulatory, Market Access, Sales and Marketing teams). • Engage with National and Regional KOL’s in the practice setting to update their understanding of the latest clinical trial data in context, and to build and maintain these relationships to facilitate scientific exchange. • Lead in country collaboration with CRO and global staff for a real-world evidence study (ARISE), including site identification, review of study protocol and study related documents, timely regulatory and ethics approval, study start up, study conduct, organize and host local investigator meetings, monitor local CRO’s performance and facilitate communication with PI’s for study and safety-related issues. • Contribute actively to building and maintaining scientific understanding of Novo Nordisk marketed products and development of portfolio products specifically GLP-1s, new generation insulins (NGIs) and Obesity. • Prepare clinical information within Market Access dossiers for submission to medical aids as part of reimbursement process application. • Apply and disseminate knowledge and utilise scientific expertise with internal and external stakeholders as a result of a comprehensive analysis of their needs, aiming to improve patient outcomes. • Utilise clinical project management skills within the medical department to simplify processes • Lead and contribute to the Novo Nordisk local publication plan. • Identify opportunities for Investigator Initiated Research and work in conjunction with PI’s to facilitate submission of proposals, protocols and relevant documents to Medical Director.--
Clinical Project Manager & Epidemiologist 05/2013 - 08/2016
National Institute for Communicable Diseases, Edenvale, Gauteng South Africa
Industry: Research
I was a clinical project manager for observational studies and Centre Epidemiologist, for the Centre for Opportunistic, Tropical and Hospital Infections (COTHI)
• Management of clinical project research targets, human resources and scheduling as per protocol, timeline and budget • Training and line management of relevant clinical project staff, including orientation, pre-study visits, site start-up and monitoring visits, monitoring of informed consent, CRF’s and study related documentation • Data monitoring and management of site data to ensure patient safety ethical and regulatory compliance • Management of field staff for clinical research surveillance programmes and epidemiological studies • Data analysis and report writing (antibiotic and antifungal drug resistance data)--
Programme Manager: Cryptococcal Screening Programme 06/2012 - 04/2013
National Institute for Communicable Diseases, Edenvale, Gauteng South Africa
Industry: Research
Programme Manager for pilot phase of a screening programme
• Manage project, clinical and research activities targets to ensure that the general and overall tasks are effectively, efficiently and cost-effectively adhered to • Undertake follow-up actions on project and research implementation activities and draft changes in the programme work plans and interim reports as required • Conducting site visits and audits to ensure programme and enrolment is in line with protocol and ethical guidelines • Co-ordination and management of central and on-site data collection from wide ranging clinics, provinces and laboratories • Managing comprehensive data entry and data analysis, protocol development and updates including ethics committee applications and hospital/clinic permissions • Assisting Principal Investigator in the management of the PEPFAR grant budget and providing logistical support to staff • Accountable for the production and dissemination of reports and participating in relevant internal, provincial, national and international meetings • Reason for leaving: Obtained a permanent position within the company--
Epidemiology intern 01/2012 - 05/2012
US Embassy South Africa: Centres for Disease Control, Pretoria, Gauteng South Africa
Industry: Public
Epidemiology intern within the CDC branch in South Africa
• Appointed as Epidemiological intern, assistant project manager and reviewer of protocols and associated PEPFAR documentation • Actively managing projects relating to PEPFAR program and partner implementation plans and assisting the National Department of Health with tasks as requested--
Field Epidemiology Resident/Medical Science Intern 01/2009 - 11/2011
National Institute for Communicable Diseases, Edenvale, Gauteng South Africa
Industry: Public
Field epidemiology resident with the SAFETP programme
• Working within the South African Field Epidemiology and Laboratory Training Programme as a Laboratory Resident • Carrying out epidemiological research, data management and analysis and ethics submission for research • Preparing research presentations and field reports, conducting site visits and coordinating for laboratory track modules--
Research Assistant (SAPPI Project): Entomology Department 02/2008 - 12/2008
Biological Control Products, Pinetown, Gauteng South Africa
Industry: Research
Research assistant within an agricultural biotechnology company.
• Sub-culturing and maintaining pure fungal cultures, inoculating cultures onto solid substrates and routine microbiological work • Isolating, investigating and maintaining plant diseases and research activities on an ongoing basis--

Rhodes University 07/2000 - 11/2004
Grahamstown, Eastern Cape, South Africa
Degree: Bachelor's Degree
Major:Biochemistry
Minor:Human Kinetics and Ergonomics
Undergraduate degree in Biochemistry and Human Movement Science

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