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Summary

International professional with more than 30 years’ experience accrued over 23 years in R&D and 7 years in the HealthCare sector. During the last 23 years gained experience in the international R&D industry in Clinical Research/Clinical Operations, Clinical Project Management and Contract Management in pharmaceuticals, biotech, medical device companies and in Contract Research Organizations. Worked on Clinical Operations’ projects, Outsourcing programs, Process re-design, Change management, Proposal reviews, analysis and technical support on behalf of Pharmaceutical, Biotech, Medical Device and Vendor organizations in the Netherlands, Belgium and Germany.
7 years of experience in the Healthcare sector as physiotherapist in different settings in the Netherlands and Germany.

Since March 2009, working as a self-employed professional, providing consultancy, interim, operational support at short and long-time projects conducted in the bio-pharmaceutical industry, medical device, vendor companies and healthcare sector.

2011 - Completed: - Green Belt in Lean, Certified Green Belt in Lean (CGBL) in accordance with the IIBLC (International Independent Board for Lean Certification). - Black Belt in Lean (BBL) curriculum (Book of Knowledge (BOK) principles in accordance with the IIBLC

2015: Graduated for Master of Science (MScBA) in Business Administration at the Radboud University in Nijmegen, the Netherlands Subject Thesis - De Cliëntenraad - de spil in het geheel -

2017: Course "Personalized Medicine"
Certifcate earned 24 May - License Number:FM4M5HMPJ8D8
https://www.coursera.org/account/accomplishments/certificate/FM4M5HMPJ8D8

 

Expertise:

*Clinical Research/Operations (CRA, CTL)
*Clinical Project Management & Trial Management (Multiple therapeutic areas)
*International Line-Management
*Strategic Outsourcing, Contract and Vendor Management
*Medical Devices experience
*Patients Treatment (Diversity of diseases)

Competencies:

*Leadership, training, coaching and people-management
*Negotiation skills and conflict resolution/mediation
*High level of multi-culture awareness
*Knowledge/Experience with Lean

 

See my blog on savings in outsourcing

During my work in particular in the outsourcing, I have seen and delivered high amounts in savings on outsourced clinical projects. I can ensure that savings up to 20% can be achieved. If you would like to know more. Contact me.

http://www.pharmcmed.com/blog/11-achievements/29-outsourcing

 

Experiences

Current Experience

  • Consultant in Clinical Research/Operations & Outsourcing
    Since March 2009

    PharmCMed is an independent life sciences consulting firm, founded by Paul Bouten that supports biopharmaceutical and 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, Procurement, (Outsourcing and Insourcing), Clinical Quality Assurance and the healthcare industry as a whole.

    For full description of services, please visit the website (www.pharmcmed.com)
    Email: paul.bouten@pharmcmed.com or info@pharmcmed.com

    PharmCMed can help to build bridges and provide the following services:

    • Services in clinical development and operations

    • Services in outsourcing field • Healthcare

    • Interim specialist for Medical Devices

     

    Latest assignment: Advise, support and drafting PMCF study (following MEDDEV 2.12 rev 2) and next stage follow-up and - monitoring process

     

    Experience has been built in:

    Medical Device studies Studies in different phases

    Urology & Women’s Health, Endoscopy, Neuromodulation
    Cardiovascular (Interventional Cardiology (TAVI, TAVR, coronary eluting stents)
    Peripheral Interventions (eluting stents)
    Rhythm Management (ICD, CRT-D devices)

    Biopharmaceutical and CRO

    Studies in phase I-IV

    Cardiovascular, CNS, Pulmonary, Imaging (Cardiovascular, Oncology), Vaccine, Auto-immune, Oncology, Women’s Health (anti-conception, Hormone Replacement Therapy (HRT)), Male anti-conception and infectious diseases

  • Owner
    Since March 2009

    A self-employed professional providing consultancy, interim, operational support at short and longtime projects conducted in the bio-pharmaceutical industry, medical device, vendor companies (i.e. Contract Research Organization) and healthcare sector.

    Ability to support in Development, Clinical Operations, Outsourcing programs, Process re-design, Change-Management, Proposal review and analysis and technical support on behalf of Pharma, Biotech, Medical Device and Vendor organizations.

Past Experience

  • (Freelance-role) Manager International Clinical Vendor Management/Outsourcing & Contracts
    November 2009 --- December 2016

    Freelance function: Providing outsourcing and vendor management support for medical devices global and local studies. Full outsourcing vs. FSP and insourcing.
    Supporting the US Global Sourcing Department with other outsourcing activities.

    Region of focus: Out of US (OUS), Europe, Middle East, Japan and Asia-Pacific (including China and India) region.

    Process:

    Supporting, managing in harmonizing the out-sourcing process at a global level
    Managing and supporting the study teams with setting-up the outsourced study (manuals) and escalation path (when needed)
    Supporting the entire process from RFI, RFP through to signed contract
    Selection of different vendors (CRO, Core-labs etc.)
    Contract and Vendor Management including:
    - Contract sign off, management of Out of Scope and sub-sequential amendments
    - Governance
    - Oversight budget and metrics and milestones
    - Project Management
    - Communication plans

    Studies in different phases Investigational Feasibility, Pre- and Post- Marketing in the following fields:

    Urology & Women’s Health, Endoscopy, Neuro-modulation
    Cardiovascular (Interventional Cardiology (TAVI, TAVR, coronary eluting stents)
    Peripheral Interventions (eluting stents)
    Rhythm Management (ICD, CRT-D devices)

  • (Freelance) Clinical Team Lead
    March 2009 --- December 2009

    Freelance function: Interim management - Clinical Team Lead (CTL) -

    Management, for 15-20 CRA's, monitoring the CAPiTA study.
    The 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)

    A study in Male or female adults aged 65 years or older conducted in the Netherlands
    Target Number of subjects 85,000


    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)

     

  • Associate Director - European Head of Outsourcing and Contracts
    July 2006 --- March 2009

    International Line-management and leadership for a team of 7 Outsourcing/Contract Managers.

    Including: - setting development plans, coaching, creating ownership for work by team, performance review, salary approval hire and fire.

    - Member of the O&C Task Force Goal: # to implement changes related to all out- and in-sourcing activities.
    The focus is on process improvement with aspects on time, quality and budget and implementation of a (revised) outsourcing strategy
    - Manager and project-owner the preferred provider initiative for the selection of the CLS
    - Team-member of preferred provider initiative for CROs
    - Team-member of the Functional Service Provider (FSP) initiative for Biometrics Service
    - Team-member of the Vendor Management database initiative

    Hands-on:

    - Outsourcing support and project management (Vendors, Hospital/Sites/Investigator contracts and Insurance)
    - Management of large amount contracts, larger volume MSA and Steering Committee (Governance) meetings
    - Writing, leading the update and maintenance of departmental Standard Operating Procedures (SOP) and Working Instructions (WI)
    - Supporting/coaching the team with negotiations and making the department visible in- and outside the organization by presenting at symposia and congresses
    - Supporting the overall savings
    - Vendor Audits (quality check on systems, processes/procedures contingency planning)

    Department responsibilities:

    Full outsourcing, FSP and insourcing all phases (phase I-IV).
    Negotiate on meeting the company targets, especially: best price, adjust to timelines and high quality.
    Contribute to the overall company savings (cost effectiveness).
    Supporting the entire process from RFI, RFP through to signed contract.
    Contract and Vendor Management including:
    - Governance
    - Oversight budget and metrics and milestones
    - Project Management

    Field: Cardiovascular, CNS, Auto-immune, Oncology and infectious diseases.

  • Director - Head of Clinical Operations Department Europe -Clinical Operations Manager-
    November 2003 --- July 2006

    Project Management and Clinical Operations Manager:
    - Responsible for the execution and conduct of phase I and II studies.

    Including:

    study set-up (strategic decision process for country and site selection), purchase study material (i.e. PK cryo-vials), protocol and CRF input, EC and CA submissions, site visits. Contract Management: - contract design, - budget & contract-negotiation with hospital and investigators sites and other external parties (CRO’s, CLS, Core-labs and specialty labs etc.) Co-monitoring and setting-up Investigator Meetings. Preparing and managing data for Review Committees. Vendor Management of third parties. Supporting and preparation of EOP- I and II packages for submission.

    Departmental Head:

    - Line-and people management for 3 Project Managers
    - Relation Management (external and internal customers (liaison with HGS Headquarters in the US, participating in the relevant Global Project Teams)

    Field, phase and countries:
    Phase I & II Rheumatoid Arthritis, 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 Manager
    July 1998 --- November 2003

    Management of the outsourcing process with different vendors (CRO’s, CLS and specialty laboratories, Core-labs, IVRS, ECG providers) for global and local studies (preclinical and phase I-IV).

    Full outsourcing, FSP, specific (Packaging, Bone-markers, Data-management, Biometrics, Medical Writing) and insourcing.
    Processing and managing Standard Operating Procedures (SOP) and Work Instruction (WI)
    Supporting the entire process from RFI, RFP through to signed contract.

    Contract and Vendor Management including:
    - Governance
    - Oversight budget and metrics and milestones
    - Project Management
    - Communication plans
    - Vendor Audits

    Field: Cardiovascular, CNS, Women’s Health (anti-conception, Hormone Replacement Therapy (HRT)), Male anti-conception

  • Clinical Research Associate (CRA)
    March 1993 --- July 1998

    International monitoring and site-management (Phase II-IV).

    Sites located in the Netherlands, Belgium and United Kingdom.

    Local Project Coordinator (LPC) with Project Management responsibilities for one program running in the Benelux.

    Field: Cardiovascular, Pulmonary Diseases, CNS, and Diagnostic Agent (Imaging - (Cardiovascular, Oncology))

    Projects involved:
    - overall number of patients and sites monitored: 1380 patients and 46 sites.

  • Physiotherapist The Nehterlands, Germany
    August 1986 --- February 1993

    Responsible for the treatment and management of patients with a diversity of diseases

    Field: Orthopedic and Neurological diseases, Psycho-somatic problems.

Personality

Self Assessment :
AdaptabilityAnalytical thinkingApproachabilityAssertivenessAttention to detailCollaborationCoordinationCreative thinkingCritical thinkingCommunicativeEfficiencyFlexibilityInnovative thinkingInterest in knowledgeIndependenceKindnessProactivityProblem solvingPerspectiveResponsibilityResult OrientedReaction to stressStrategic thinkingSociabilitySelf-disciplineService orientedTrust

Knowledge

Self Assessment :
AntibodiesAdverse Events (AE)AuditingBiopharmaceuticalsBiomedical SciencesBiomarkersBudget ProcessBusiness Process ImprovementBudget ManagementBusiness DevelopmentBusiness IntelligenceBudgetingBudget NegotiationClinical researchClinical operationsCardiovascular diseasesClinical trial audits and inspectionsClinical trial designCross-functional team leadershipClinical Trial Management System (CTMS)CancerCROCommunication SkillsClinical trialsCNSContinuous ImprovementCRF designCoachingClinical monitoringClinical DevelopmentContract negotiationChange ManagementClinical trial budgetingClinical trial management DiabetesEntrepreneurshipInternational Project ManagementLeadership Medical devices NegotiationOutsourcingpeople managementPhysical medicine and rehabilitationPhases of clinical development (phase I to IV) Scientific writing R&DoncologyRegulatory RequirementsRegulatory affairsProject ManagementStudy protocolsStandard Operating Procedure (SOP)TeamworkPreclinical Research Phase IPhase IIPhase IIIPhase IVMedical DevicesInterventional CardiologyPulmonary diseasesCardiologyMedical ImagingNeurologyRegulatory submissionsEMAFDAVaccines
LinkedIn Assessment :
Clinical trialsCROOutsourcingClinical DevelopmentPharmaceutical IndustryClinical researchTrainingMedical DevicesCTMSClinical operationsClinical monitoringBiotechnologyNegotiationMedical writingBiopharmaceuticalsNeurologyVaccinesR&DDirect Patient CareLine ManagementLifesciencesGCPLife SciencesVendor ManagementPhysical TherapyQuality ManagementLean ThinkingProject ManagementGood Clinical Practice (GCP)

Skills and Expertise

Self Assessment :
Create SOPs Interact with nurses Interact with physicians Monitor a clinical studyAct as the main line of communication between the sponsor and the investigatorAttend investigator meetingbudgeting of R&D activities Build and manage the Trial Master File (TMF) Develop clinical trial protocolsAdvise on strategyCoach and provide guidance to clinical staff.Collaborate with principal investigatorCommunicate effectively on different company levelsContract approvalDevelop study budgetDirect co-workersInteract with CROsMaintain strong relationshipsManage vendor budgetsNegotiate budget NegotiationPeople managementDesign case record form (CRF)Design protocolWork collaboratively with the other members of the clinical research team Monitor Key Performance Indicators (KPI's)Review monitoring reportsIdentify risksIdentify investigatorsIdentify sitesPrepare regulatory documentsInteract with KOL

Education

  • MScBA in Business Administration (Bedrijfskunde) from Radboud University Nijmegen in 2015
  • BBL in Lean from International Independent Board for Lean Certification vzw (IIBLC) - (BBL) Black Belt in Lean in 2011
  • CGBL in Lean from International Independent Board for Lean Certification vzw (IIBLC) in 2011
  • in (BMG) Beleid & Management Gezondheidszorg (Health Policy & Management) from Erasmus University Rotterdam in 1998
  • Master of Science (MSc) in Bio-Medical Sciences from Radboud University Nijmegen in 1992
  • Bachelor of Health Science (BHS) in Physiotherapy from Hogeschool van Arnhem en Nijmegen in 1986

Training and Certification

  • Masterclass in Data Science and Business (Law) in 2017 Training
  • Masterclass in Data Science and Business (Entrepreneurship) in 2016 Training
  • Personalized Medicine in 2017 Certification
  • Black Belt in Lean in 2011 Certification
  • Certified Green Belt in Lean (CGBL) acc IIBLC in 2011 Certification

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
English
Full Proficiency
German
Full Proficiency
French
Elementary Proficiency

Work Preferences

  • Notice Period:
    1 week
  • Positions I am interested in:
    Chief Strategy Officer Associate Director Clinical Operations Biomedical Scientist CEO Clinical Development Consultant Clinical Project Leader Clinical Research Consultant CSO Development Manager General Manager Managing Director Medical Advisor R&D Director Team Leader Clinical Director Europe Clinical Operations Manager Clinical Research Manager
  • Work From Home:
    No
  • Work Regime:
    Permanent position :    100% FTE
    BrightOwl freelancer :    40 Hours per week
  • International:
    Yes

Publications

    Expert has 1 publications (Will be avalible with full profile)

Area / Region

Nijmegen, Netherlands

Others

Driving License
  • Yes