Since 1996 experience in clinical research in both pharma and medical device industry as a Study Coordinator, CRA, Project Manager (Local/European/Global), Manager Clinical Research (including line-management) and Manager Medical Affairs. Five (5) years experience in training and training management for pharma, biotech and medical devices companies. Specialized in complex medical device studies including on-site technical case support (24/7).Discover the offered services!
As a Medical Affairs Manager for Medical Devices Hans can provide every service a Medical Device Company may need – from development / conduct of Post Marketing studies to other types of scientific & congress support, medical education and Key Opinion Leader Management (including preparing the KOL for presentations. Hans Tielemans worked almost 4 years as a Medical Affairs Manager in a Medical Device company.
A good Clinical Research Associate must have excellent communication skills to ensure site staff understands the necessity of the conduct of studies under strict regulations and compliance to these regulations. In addition to this, we believe increasingly stringent company deadlines can only be met by an increased flexibility of the CRA. Throughout his career as Project Manager, Hans Tielemans continued CRA activities, mostly to monitor / site manage the center of the Principal Investigator. For some studies, CRA activities includes technical on)site support.
Experienced in the management of National / European / Global Clinical Studies in medical devices and pharmaceutical industry. From Phase I (First in Man) to Phase IV (Post Marketing Studies). Responsibilities from proof of concept, study feasibility, study design development, protocol / CRF writing, site selection and qualification, site initiation, training for study team and site staff, organizing investigator / CRA meetings, on-site support, …. up to support for final presentations / publications. Hans Tielemans’ main experience lies in the management of complex Clinical Studies in Medical Devices although also experienced in Pharmaceutical Studies.
As a study nurse Hans is the interface between investigators and patients. Responsibilities depend on the type of the study and the assigned responsibilities and can vary between CRF completion only to a full set-up and conduct of the study within the hospital setting, including sponsor contract and/or negotiations. Lately Hans Tielemans conducted two studies as a Study Nurse in a setting where patients were visited in their home environment to test new medical devices for intermittent urinary catheterization.
Developing a training is easy. It is searching for a methodology to ensure the training content is incorporated in the training attendee(s) mind. Training can be individual / in small groups / large groups. Can be a one time training / repetitive training with our without preparation / assignments to be completed by the trainees. With no, limited or many practical exercises. Hans Tielemans was 4 years Head of Training of Novellas Healthcare’s The Clinical College – a training company with focus on the Healthcare Environment and provided training related to Clinical Research, Medical, Sales, Regulatory and Personal Development. He developed several courses such as Clinical Project Management, Science Based Selling Skills. More recent, Hans was co-trainer for a STAR Program – Managing Clinical Studies in Medical Devices.
Studies in Medical Device can be very complex due to the nature of the study design and/or the use of a totally novel device which needs to be trained on externsively prior to applying it in a Clinical Research setting. The past years, Hans Tielemans was more and more involved in the training of physicians in the use of medical devices in urgent threatments. Goal is to get physicians acquainted with the devices and to ensure that the novel device is becoming part of the urgency therapy by different types of training such as – hands-on, dry run, animal labs, case assistance. Depending on the type of study case support can within and/or outside business hours.
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