Paul Bouten

Expertise: *Clinical Research/Operations (International CRA, CTL) *Clinical Project Management & Trial Management *Outsourcing, Contract and Vendor Management *Line-Management *Vendor Quality checks and Audits *Medical Devices - IC and IP (TAVI, TAVR, eluting stents) - RM (ICD, CRT-D devices) *Patients Treatment Competencies: *Leadership, training and people-management *Negotiation skills and conflict resolution *High level of multi-culture awareness *Knowledge/Experience with Lean

Vendor Management/Outsourcing & Contracts Manager. Provided support to the company with the outsourcing of studies in Europe, Outside of the US, Japan and Asia-Pacific. Experience in: Class III, CE-Mark, Investigational Feasibility, Pre- and Post- Marketing in the following fields: Urology & Women’s Health, Endoscopy, Neuromodulation Cardiovascular (Interventional Cardiology (TAVI, TAVR, coronary eluting stents) Peripheral Interventions (eluting stents) Rhythm Management (ICD, CRT-D devices)

Clinical Team Lead Management/Interim management o Study management 15-20 CRAs, monitoring the CAPiTA study (http://clinicaltrials.gov/ct2/show/NCT00744263?term=vaccine+and+capita&rank=6; )

Line Manager, for 7 Sourcing Managers Responsible for the outsourcing of Clinical Studies all phases (I-IV) and insourcing of staff in Europe and RoW. Full outsourcing and FSP Involved in strategical processing and change management Outsourcing to CRO, all service providers (CLS, IVRS, ECG, speciality Labs) Insourcing staff: CRAs, Proj Managers, Data Managers, Med Writers, BioStatisticans

ClinOps Manager: Line-Manager for 3 Project Managers Project Management Responsible for the conduct of Clinical Studies in Europe (phase I-II) Field: Oncology (Solid), Rheumatoid Arthritis & HVC

Responsible for the outsourcing of Clinical Studies (Phase I-IV) and insourcing of staff. Full Outsourcing and FSP Supporting Pre-clinical outsourcing. Outsourcing: CROs, CLS, ECG, EEG, IVRS, speciality Lab

Responsible for the monitoring of clinical studies in the Netherlands, Belgium and United Kingdom Field: CardioVascular, CNS, Pulmonary Disease, Oncology, Diagnostica. Phase II-IV The overall number of patients and sites monitored for all projects was: 1380 patients and 46 sites.

Physiotherapist working in the Netherlands and Germany in Private and Hospital Settings. Permanent and Interim functions

Title Thesis: De Cliëntenraad, de spil in het geheel Translation: The client-council, the integral linchpin Describe suggestions for the structure client-council, knowledge, skills members to optimize the relation with board Published (http://ncz.nl/thesis-de-clientenraad-de-spil-in-het-geheel/)

Completed a Black (BBL) in Lean curriculum (Book of Knowledge (BOK) in accordance with the International Independent Board for Lean Certification (IIBLC)

Completed the Green Belt in Lean curriculum (Book of Knowledge (BOK). I am certified Green Belt in Lean (CGBL) in accordance with the International Independent Board for Lean Certification (IIBLC).

Qualification Statement: 4 September 1986 BIG Register Number: 49033245804 (2 March 1998)