Paul Bouten Email and Phone Number
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Seasoned International pharmaceutical professional with an entrepreneurial approach experienced in Clinical Research, Operations, Project Management, Regulatory Affairs, Procurement, Outsourcing & Contract Management built in pharmaceuticals, biotech, medical device companies and Contract Research Organizations in the Netherlands, Belgium and Germany.Experience built in the Healthcare sector as physiotherapist in different settings in the Netherlands and Germany.Registered Board Certified Medical Affairs Specialist (BCMAS) Hands-on and leadership experience: setting up, building, leading teams, change-management, developing outsourcing strategies, how to optimize outsourcing to get the best team for the best price and manage it. How can I help you or your company, what is my added value? - Thinking, approach with an entrepreneurial view. Just different. I can support you in managing, developing your studies with an eye-opener for less money, to beat timelines, keep quality, think “out of the box” and help developing different ways/paths to realize your targets. When to outsource -– it is one of my core business arenas’ and can support -hands-on- in negotiations, help you in developing the bid-tools, matrix, suggestion in strategic approaches, how to save money (>20% on outsourced studies) and bind the dedicated external party to your projects.(see blog www.pharmcmed.com)What does that mean for you?- Cost savings, profit increase, quality work, change in mind set. Expertise: - Clinical Research- Clinical Operations (CRA, CTL, COM, CPM, (Head) MSL)- Quality Audits - Regulatory Affairs- Line Management (Head Clinical Operations & Head O&C)- Procurement, Outsourcing & Contract, Vendor Management - Medical Devices Competencies:- Leadership & people-management- “Out of the box” thinker, innovative- Negotiation skills & conflict resolution/mediation- Multi-culture awareness- Change Management- Outcome Oriented - FlexibleCertificate can also be reviewed at the blog section www.pharmcmed.com Link: http://www.pharmcmed.com/courses
Pharmcmed (- Freelance Function With A Biotech Client -)
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Pharmcmed (- Freelance Function With A Biotech Client -)Netherlands
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Consultant Clinical Sourcing ManagerPharmcmed (- Freelance Function With A Biotech Client -) Jul 2019 - PresentAssignment: - Support client with the outsourcing of their clinical studies (all clinical phases), Bio-Analytical, Quality and Regulatory Affairs services.Engaged in designing/building - tools - finding and setting up the state to art outsourcing Data-Base- Indication: Rare Diseases (Muscle and Neurological disorder), oncology, vaccines
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Professional In Clinical Research/Operations, Regulatory Affairs & OutsourcingPharmcmed Mar 2009 - PresentNijmegen, Gelderland, NlPharmCMed is founded by Paul Bouten that supports biopharmaceutical, medical device companies, service providers and the healthcare industry.Its core competence is in providing clients with outstanding services and solutions in areas of Research and Development (R&D), Clinical Operations, Regulatory Affairs, Procurement, (In- & Outsourcing), Quality Assurance and the healthcare industry.For full description of services, please visit www.pharmcmed.comEmail: paul.bouten@pharmcmed.com or Mobile: +31 653758045PharmCMed can help to build bridges and provide the following services:Services in clinical development & operationsServices in outsourcing fieldHealthcareInterim specialist for Medical DevicesRegulatory AffairsExperience has been built in:Medical DevicesStudies in different phasesUrology & Women’s Health, Endoscopy, Neuro-modulationCardiovascular (TAVI/R, coronary eluting stents)Peripheral Interventions (stents) Rhythm Management (ICD, CRT-D devices)Biopharmaceutical and CROStudies in phase I-IVCardiovascular, CNS, Pulmonary, Imaging, Vaccine, Auto-immune, Oncology, Women’s Health (HRT) Male anti-conception, infectious diseases & Ophthalmology, Metabolic Disorder, Gene TherapyRegistered Board Certified Medical Affairs Specialist (BCMAS)Assignments:2019Consultant Clinical Sourcing ManagerRegulatory Affairs Support - Netherlands 2018-2019Associate Director Project-ManagementOphthalmology (IND, Phase II) Country USHead Project Manager - Medical Sciences Liaison (MSL)Management 5 MSLs in Europe Intermediary Biotech Company & CRO’s Rheumatoid Arthritis Countries West & EEC2017Advise PMCF study (MEDDEV 2.12/rev 2)2009-2016Outsourcing support different companies and BSCField: CNS, Oncology, Devices Training:CAR-T cellsArtificial Intelligence - MIT Sloan School of Management Personalized & Precision MedicineOncology Global Medical Device Regulatory Affairs International Pharmaceutical Regulatory Affairs
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"Available" To Support You And Your Company In This Challenging Time (2022 - 203X)- Pharmcmed - How Can I Help You Or Your Company, What Is My Added Value? - Mar 2009 - PresentI am passionate about and Interested in leaving the current -"Paths of development"-- Rethink development and be creative -outside the box thinking- How can we develop medication and conduct clinical studies differently, taking in mind technology? Means simpler, shorter timelines, cheaper, combination of products with data available (Advanced Technology i.e. Blockchain, Big Data, AI, Machine Learning, Deep Learning, NLP, algorithm). - How to use wearable data? - How to use implement RWE/RWD data for earlier phase studies?- What is the effect of multiple pathology, age on medication intake, should this more Personalized? - Personalized Medicine, will it impact or change the drug discovery approach, what is the effect on future development? All above will have effect on cost. My experience as learned that cost savings in outsourcing up till 20% can be achieved - (see blog PharmCMed)I am looking for opportunities to join, meet companies and/or peers who share the same vision. Interested in opportunities with: Small Biotech, Spin-Off, Devices, Companies (& CROs) believing in changes considering above technology, Healthcare.Or possibilities to step in Health-tech Ventures in "entrepreneurial role' or "- Management Buy In (MBI)".Functions:# Clinical Operations, # Development, # Project Management, # Regulatory Affairs, # Outsourcing & Vendor Management, # Procurement. Please review for more information - www.pharmcmed.com Contact information: paul.bouten@pharmcmed.com or Mobile: +31 6 53758045Training: -see certificate, badges- www.pharmcmed.com – blog -courseChimeric antigen receptor (CAR) T cells Drug Safety, Pharmacovigilance, Pharmacokinetics, and Pharmacodynamics Artificial Intelligence: Implications for Business StrategyPersonalized and Precision MedicineOncology Regulatory Affairs:# Global Medical Device Regulatory # International Pharmaceutical Regulatory Affairs
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PartnerHealth Valley Netherlands Mar 2017 - PresentNijmegen, Gelderland, Nl -
OwnerPharmconmed = Pharmcmed Mar 2009 - PresentFor services to conduct I refer to summary PharmCMed (www.pharmcmed.com) PharmConMed or PharmCMed is the same organization. Interesting topics are the blogs on the website.For contact: Paul BoutenT: +31 6 53 75 80 45E: paul.bouten@pharmcmed.comW: www.pharmcmed.com
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Associate Director Project ManagementPharmcmed (- Freelance Role For A Biotech Client-) May 2018 - Mar 2020Assignment: - Associate Director Project Management Phase II IND study Management of 16 FTE.Study Team:CRAs, Data-Management, Biostats, Medical Writing, Pharmacovigilance, Safety and Regulatory Affairs.Located in the US (=full remote (study) management) Indication: OphthalmologyCountry: Only Centers in the US
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Regulatory Affairs SupportPharmcmed (- Freelance Function For A Biotech Client -) Jan 2019 - Jan 2020Assignment: - Support client with Regulatory Affairs business (i.e. reviewing documents and making proof, adaptation-update CTAs, submissions CA, EC)
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Manager International Clinical Vendor Management/Outsourcing & ContractsBoston Scientific Corporation Nov 2009 - Dec 2016Marlborough, Ma, UsFreelance function in Medical DevicesProvided outsourcing and vendor management support for global and local medical devices studies. Supported the US Procurement - Global Sourcing Department with their outsourcing activities. Regions involved:Europe, Middle East, Japan and Asia-Pacific (including China and India) regionScope: Full outsourcing vs. FSP and insourcing Projects:- Management and driving the entire process from RFI, RFP, vendor selection(CRO, Core-labs, etc.) through till signed contract and follow-up - vendor oversight management, escalation plan/path.- Process (optimization) for RFI-P till governance, vendor oversight management, RBM (Risk Based Monitoring), centralized and site monitoring, Data-safety, Management of CAPA, NCEP.- Managing and supporting the study teams with setting-up the outsourced study (manuals) and harmonizing the outsourcing process.Studies in different phasesInvestigational Feasibility, Pre- and Post- Marketing in the following fields:Urology & Women’s Health, Endoscopy, Neuro-modulationCardiovascular (Interventional Cardiology (TAVI, TAVR, coronary eluting stents)Peripheral Interventions (eluting stents) Rhythm Management (ICD, CRT-D devices) -
Clinical Team Lead (Ctl)Quintiles Mar 2009 - Dec 2009Durham, North Carolina, UsFreelance function:Management of 15-20 FTE (15-20 CRA's) monitoring the CAPiTA study. Act as intermediary between CRO’s and Pharma Company. Interim project management - Clinical Team Lead (CTL) – in a matrix-structureThe CAPiTA study is a vaccine study to evaluate 13-valent pneumococcal conjugate vaccine (PCV13) for the prevention of vaccine-type invasive and noninvasive Community-Acquired Pneumonia immunization Trial in Adults (CAPiTA) Official Title: A Phase 4, Randomized, Placebo-Controlled Clinical Trial of 13-valent Pneumococcal Conjugate Vaccine Efficacy in Prevention of Vaccine-Serotype Pneumococcal Community-Acquired Pneumonia and Invasive Pneumococcal Disease.(http://clinicaltrials.gov/ct2/show/NCT00744263?term=vaccine+and+capita&rank=6) -
European Head Of Outsourcing And ContractsUcb Pharma, Belgium Jul 2006 - Mar 2009Brussels, BeLevel: Associate DirectorDirect Management and leadership for 8 FTE (team of 8 Outsourcing & Contract Managers) and indirect management of CRO-Staff.Projects: Change Management, Re-design, improvement of outsourcing processes and implementation (revised) outsourcing strategy, managed by the -O&C Task Force -.Goal: To redesign the process around out- and in-sourcing activities with the focus on the following aspects: on time, quality and budget, (to simplify the processes, tools).Member and Lead of the -O&C Task Force-: - Project Manager (owner):- Preferred provider initiative for the selection of the CLS- Lead of the Functional Service Provider (FSP) initiative for Biometrics ServiceTeam-member of preferred provider initiative for CROs and Vendor Management database initiative (including Auction Database)Department responsibilities: - Management of the full outsourcing process from RFI/P (budget, contract negotiation) till Vendor, Oversight Management for global, local studies (phase I-IV).- Insourcing of temporary personnel (staff shortness).- Advice and management of Hospital/Sites/Investigator contracts and Insurance.- Leading, Writing, maintaining Standard Operating Procedures (SOP) and Work Instruction (WI), development tools (templates, bid-grids, contracts, Amendments, KPI, metrics). - Conducting Vendor Audits (QA/QC).Overall interest for Department and O&C managers:Making yourself and the department visible in- and outside the organization by presenting at symposia and congresses (example PCT)Contribute to the overall company savings (cost effectiveness).Field: Cardiovascular, CNS, Auto-immune, Oncology and infectious diseases. -
Head Of Clinical Operations Department Europe -Clinical Operations Manager-Human Genome Sciences, Germany Nov 2003 - Jul 2006Rockville, Md, UsLevel: DirectorDirect management of 3FTE's (3 Project Managers) and indirect management of CRO’s. An entrepreneurial function, to build the European Clinical Operations Department and number of studies to conduct in Europe. The department has grown with 3 Project Managers and number of studies in Oncology, Rheumatoid Arthritis and Hepatitis C.Project Management, Medical Affairs Liaison and Clinical Operations Manager:- Responsible for the set-up (strategic decision for country and site selection), execution, conduct studies, support and preparation of EOP- I and II packages for submission.- Vendor Management of third parties and investigators.Departmental Head: - Management & leadership for 3 Project ManagersField, phase and countries: Phase I & IIRheumatoid Arthritis (IND), SLE, Hepatitis C and Oncology (MAb (and combination with Chemotherapy) Solid Tumors, Hematological Tumors)Countries involved: - Germany, the Netherlands, France, UK, Poland, Czech and Romania. -
Cro ManagerNv Organon, The Netherlands Jul 1998 - Nov 2003Jersey City, Nj, UsManagement of the full outsourcing process from RFI/P (budget, contract negotiation), third party selection till Vendor, Oversight Management for global, local studies (preclinical and phase I-IV) and insourcing of temporary personnel (staff shortness).External (Third) parties: CRO’s, Phase I, ARO’s, Research Units, Pre-clinical CRO’s, CLS and specialty laboratories (Bone-markers, PK-PD), Core-labs (Imaging), IVRS, ECG providers, Packaging, one shop: CRA’s, Data-management, Biometrics, Medical Writing.Projects: - Change Management - change in Strategy: Tactical to strategically outsourcing, preferred vendors, FSP, Re-design processes.Project Management: - Writing, maintaining Standard Operating Procedures (SOP) and Work Instruction (WI). - Training staff (Study Teams).- Developing tools (templates, bid-grids, contracts, amendments, KPI, metrics). - Conducting Vendor Audits (QA/QC). Field: Cardiovascular, CNS, Women’s Health (anti-conception, Hormone Replacement Therapy (HRT)), Male anti-conception. -
Clinical Research AssociateCovance Mar 1993 - Jul 1998Princeton, New Jersey, UsAn international role: Responsible for Monitoring and site-management (Phase II-IV).Sites located in the Netherlands, Belgium and United Kingdom.Local Project Coordinator (LPC)/Project Management: project in Pulmonary Diseases in the Benelux.Field: Cardiovascular (IND studies), Pulmonary Diseases, CNS, and Diagnostic Agent (Imaging - (Cardiovascular, Oncology))Projects involved:Overall number of patients monitored is 1380 in 46 sites across 3 countries (Netherlands, Belgium and UK). -
PhysiotherapistDifferent Physiotherapy Settings In The Netherlands And Germany 1986 - 1993Responsible for the treatment and management of patients. i.e. Orthopedic, Auto-immune (RA), CNS (MS, CVA, Parkinson, Neuro-muscular disorders (muscle dystrophia) and Cardio-Vascular in Netherlands and Germany.
Paul Bouten Skills
Paul Bouten Education Details
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Radboud UniversityBusiness Administration (Bedrijfskunde) -
Open UniversiteitHealth Sciences
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Erasmus University Rotterdam(Bmg) Beleid & Management Gezondheidszorg (Health Policy & Management)
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Radboud UniversityBio-Medical Sciences
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Han University Of Applied SciencesPhysiotherapy
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Pax Christi College Druten
Frequently Asked Questions about Paul Bouten
What company does Paul Bouten work for?
Paul Bouten works for Pharmcmed (- Freelance Function With A Biotech Client -)
What is Paul Bouten's role at the current company?
Paul Bouten's current role is Professional in Clinical Research/Operations, Regulatory Affairs & Outsourcing.
What is Paul Bouten's email address?
Paul Bouten's email address is pa****@****anet.nl
What schools did Paul Bouten attend?
Paul Bouten attended Radboud University, Open Universiteit, Erasmus University Rotterdam, Radboud University, Han University Of Applied Sciences, Pax Christi College Druten.
What are some of Paul Bouten's interests?
Paul Bouten has interest in Health.
What skills is Paul Bouten known for?
Paul Bouten has skills like Clinical Trials, Cro, Outsourcing, Clinical Development, Pharmaceutical Industry, Clinical Research, Training, Medical Devices, Ctms, Clinical Operations, Clinical Monitoring, Biotechnology.
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