Michael Holdsworth work email
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Michael Holdsworth personal email
I have 9 years experience in clinical data management, and have worked for a number of multinational and local organizations managing staff and implementing data systems and quality management processes. I am proficient in SQL, Oracle, Edit Check Language, and SAS programming. Before entering the data management field I spent 4 years in IT as an Oracle Developer, and this was preceded by 3 years in teaching. In 2002 I joined an internationally-recognized non-governmental research organisation specializing in HIV research. I participated in a wide variety of managerial and data management tasks, including design and maintenance of research databases; data staff management; design of departmental organograms; development of standard operating procedures; writing of data quality management plans; and design and implementation of quality control and quality assurance processes. I contributed to the development of the overall organizational strategy, participated in developing and growing the data management department, and, during my tenure, participated in the implementation of the DataFax Clinical Data Management System.In 2006 I joined a very large multi-national pharmaceutical company. During this period, I ran a data management department specialising in data management for post marketing studies. My activities included developing and writing standard operating procedures, managing staff, developing research databases, implementing quality management procedures, SAS programming, and producing descriptive statistical reports.I joined ACRO in 2008, where I hold the position of Departmental Manager. My responsibilities include directing the implementation and maintenance of data management systems and processes for clinical research trials and post marketing studies.Specialties: Senior Data Manager, Departmental Manager and DataFax System Specialist.
African Clinical Research Organisation
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Departmental Manager (Data Management)African Clinical Research Organisation Apr 2008 - PresentACRO is the first South African, full-service, black economic empowerment, contract research organization. ACRO is a for-profit company, launched in August 2007. The company was set up through collaboration between LIFElab, the commercial arm of the East Coast Biotechnology Innovation Centre (a trust established by the South African Government Department of Science and Technology to implement the National Biotechnology Strategy), and Batswadi Pharmaceuticals, a black-empowered company with a focus on biotechnology. ACRO offers services both in South Africa and other African regions.I run ACRO’s data management department and my duties broadly include the following:• Establish and maintain a long term vision and strategy for ACRO data management.• Develop the data management department in accordance with the vision and strategy.• Employ, oversee and manage data management staff and daily activities.• Establish and maintain successful relationships with partner and client organisations.• Participate in the Marketing Strategy• Write and present proposals• Ensure adherence to international data management standards• Write SOPs and WPGs• Ensure that the department is Audit Ready• Set and manage the departmental budget• Develop and present training
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Departmental Manager (Data Management)Sanofi-Aventis Nov 2006 - Mar 2008Sanofi-aventis is a multi-national pharmaceutical company. They are the largest pharmaceutical company in Europe, and the third largest in the world.I ran a small data management department for the South African Affiliate, where we did Real World Data Management on phase IV studies, Post-authorisation surveys and Market Surveys.The department performed all data management activities from CRF Development, Database Development, Quality Control, Quality Assurance and finally we produced Descriptive Analyses in SAS (Statistical Analysis Software). -
Senior Clinical Database ManagerPopulation Council Feb 2006 - Oct 2006The Population Council is a non-profit, non-governmental organization specializing in population related Research.I worked for the Contraceptive Development division, working closely with the protocol team to develop Case Report Forms for their phase III Contraceptive Vaginal Ring Study. I was also responsible for setting up the database, and implementing Quality Control and Quality Assurance processes. In August I returned to South Africa due to family problems, but continued to work remotely for the Population Council developing Data Quality Management Plans and SOPs. During this time, I also did consulting work for Perinatal HIV Research Unit revising their Work Practice Guidelines, and auditing six of their studies. -
Clinical Research Data Manager And Datafax System SpecialistPerinatal Hiv Research Unit (Phru) Sep 2002 - Jan 2006PHRU is a non-profit, non-government funded, research organization, specialising in HIV/Aids research.I participated in a diverse range of Managerial and Data Managerial tasks. Some of these activities vary from designing and maintaining research databases, managing data staff, designing departmental organograms, participating in the development of Standard Operating Procedures, writing Data Quality Management Plans, providing Data Management for Clinical Trials, managing the Clinic Information System, and participating in the development of PHRU organizational strategy.I held the position of DataFax Administrator, and I was responsible for the effective operation of DataFax in the PHRU environment. This position involved:• Initiating and participating in training for the following datafax responsibilities: DF Validation, CRF design, DF study setup, Edit Check language, batch edit checks, DF reports, and exporting data from DataFax • Working in UNIX • Liaising with the DataFax Distributor (CDSI) concerning problems, patches, upgrades and license issues • Controlling access and permissions within DataFax • Working with IT on matters involving the installation, restoration and maintenance of DataFax related hardware and software• Maintain DataFax specific Standard Operating Procedures• Participate in, and provide guidance on all matters concerning DataFax study setup and maintenance• Setup and manage DataFax studies• Manage, and assign responsibilities to, staff working on datafax studies
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Oracle DeveloperStandard Corporate And Merchant Bank Jan 1998 - Aug 2002SCMB is a major South African merchant bank. I developed and maintained the Unquoted Equities System (a custom written Oracle Application used for over the counter trading of unlisted companies in the South African market). I was instrumental in the redevelopment of this system, and spent time fine-tuning the business processes as well as enhancing the system.Responsible for the Car Scheme Application (a custom written Oracle Application). This application involves a web server, and web deployed Oracle forms, and considerable experience was gained in this area. The application was later rewritten in Java.For the last 18 months of my employment, I was responsible for the General Ledger installation of Oracle Financials in Financial Control. This installation runs the foreign currency ledger for SCMB, and has daily transactions in excess of 20 billion rand. Time was spent supporting this huge installation, and working very closely with the business users to sort out errors and develop reports.
Michael Holdsworth Skills
Michael Holdsworth Education Details
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University Of WitwatersrandEnglish, Psychology And History
Frequently Asked Questions about Michael Holdsworth
What company does Michael Holdsworth work for?
Michael Holdsworth works for African Clinical Research Organisation
What is Michael Holdsworth's role at the current company?
Michael Holdsworth's current role is Senior Clinical Data Manager, Departmental Manager and DataFax System Specialist.
What is Michael Holdsworth's email address?
Michael Holdsworth's email address is mi****@****o.co.za
What schools did Michael Holdsworth attend?
Michael Holdsworth attended University Of Witwatersrand.
What skills is Michael Holdsworth known for?
Michael Holdsworth has skills like Clinical Data Management, Data Management, Clinical Trials, Pharmaceutical Industry, Training, Cro, Research, Clinical Research, Project Management, Quality Assurance, Protocol, Management.
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