Van Dijk Life Sciences Consultancy Providing interim management and consultancy for healthcare companies.

Julius Clinical is an Academic Research Organisation with a CRO infrastructure, dedicated to both operational and academic excellence. Julius Clinical offers an extensive range of services that can be tailored to meet the needs of (pharmaceutical) partners. A ‘one-size-fits-all’ approach is rejected, in favour of one based on flexibility, creativity, and innovation. To enable a customised approach and deliver a high quality service requires a highly professional and committed organisation. Heading up the operations, I'm ensuring Julius operational delivery and drive continued improvement of the organisation and it's infrastructure to meet and exceed customer expectations.

Responsibility of a global team that consist of three distinct parts: Around 300 RSU Leads and Regulatory Advisors. This is a specialized team leaders focused on taking the assigned projects through the process of Site Identification, obtaining the required approvals from Regulatory Agencies and Medical Ethical Review Committees etc to ensure that all legal and ethical requirements are fulfilled before studies can be initiated at our investigative sites. A team of 50 Regulatory Advisors that are highly specialized to support development of materials required for initial and ongoing clinical trial applications to Regulatory Agencies and Ethics Committees. A new team was build from zero in April 2015 to consist of over 300 Clinical Leads by the end of 2015. The Clinical Leads have full responsibility over the delivery of the clinical proportion of our projects whereby they have a prime focus on site activation and patient recruitment. They are supported by technology and a support team to ensure that they have all pertinent trial data at their availability at all times to enable close management of their studies and allow for quick decision making when course corrections are required

In this role I was collaborating in a senior management team that was tasked to reconsider the Quintiles clinical organisation and implement changes to ensure it is set-up for continued and growing success in the years to come. The objectives were far reaching and included:- reconsideration and re-configuration of the Project Leadership structure,- changes to the support of the bidding process for potential new projects. - changes to the transfer from projects from the bidding stage to operations to ensure consistent execution against the set strategy. - increased and improved focus on patient recruitment into our trials

Quintiles is dedicated to providing therapeutic expertise and operational excellence in delivery of the clinical trials it is undertaking for it's customers. The Cardiovascular and Metabolic Therapeutic Delivery Unit comprises approx 205 project management professionals and medical experts spread over 28 countries. as TDU Head I am tasked to- ensure flawless delivery in quality, timelines and budget for the trials managed throughout the group. - develop strategies for continued growth of the unit and Quintiles, and further strengthening of our therapeutic expertise- build and strengthen strategic partnerships with our customers- drive innovations in the undertaking of cardiovascular and metabolic clinical trials to make clinical trials more efficiencient, helping us to deliver more cost-effective trial to our customers and bring new medicines to patients faster.The Cardiovascular Metabolic TDU undertake studies in most cardiovascular and metabolic indications, which range from small single site studies to global studies in which more than 1500 sites in 42 counries participate.

Responsible for a global group of approx. 80 professionals working in Project Management in cardiovascular clinical research. Projects under management of the group span from single site 30 patient studies, till full service 15.000+ patient studies.

Ensuring the delivery of large multi-site full service international cardiovascular trials, taking full responsibility for end-to-end delivery to customer expectations and timelines, whilst maintaining profitability. Trials have spanned over 70 different countries, up to 1.000 sites. Services delivered include project management, regulatory and start-up, monitoring, data management, biostatistics, patient recruitment, medical and safety, endpoint management,, call center, IMP management and delivery and central lab services.

Really a combination of marketing, sales and consultant. Supporting customers with the implementation of remote Data Capture Technology in their pharmaceutical or CRO organisation. This included the implementation of new IT hardware, the revision of procedures and making organisational adjustments required to get the maximum benefit of the new technology.

Combining line and project management, I was responsible for up to 12 clinical trials at a time, both in a hospital and GP setting. Succesfully implemented an innovative remote data capture technology by closely integrating the data management and clinical team.