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Summary

a Career is like a spartacus trail run: you prepare for it and commit to running the 12k obstacle course. at the start, the course may appear daunting, it may be rainy and muddy; you wonder why you are there and whether you really want to do this or really can. then you start running and the adrenaline begins to flow. but unexpectedly you are confronted by what seems to be an insurmountable obstacle. suddenly those you were running with or even against are at your side. someone is giving you a knee up from under and someone above extends a hand to pull you up and over. you started the race as an individual and you end as a team. during the race, you learned to adjust your goals to the goals of others. crossing the finish line is not simply completing your own goals, but realizing your goals in those of others. finishing a 12k race becomes a personal achievement and a collective accomplishment. my 28-year Career in Clinical research has been a race of strength, driven by passion, supported by the Teamwork of colleagues. i no longer hesitate at obstacles: i look for the knee-up or provide the hand-over. leading global cross-functional teams of process owners and smes, my most recent responsibilities focused on risk assessments, root cause investigations, and corrective and preventive action Planning (capas), to help colleagues get over their regulatory hurdles in an efficient and compliant way. quick to identify the larger issues that underlie and surround Clinical research hurdles, i am guided by what is possible, not simply by what we have now. i am still running the race, driven by an understanding as to how quality, Compliance, and Risk Management can promote Innovation in Clinical research that will develop safe and effective medicines that meet patient real world needs. contact me at kries.declerck@gmail.com, we can talk about capas with bowties. specialties: quality, Risk Management, Problem Solving, Root Cause Analysis, process improvement, Auditing

Experiences

Past Experience

  • Global Quality Lead

    March 2011 --- January 2016
    bringing Business Process owners and subject matter experts together to agree on the problem statement of a quality issue, identify true root causes and develop a risk-based capa plan. design and deliver interactive case-based Training on the capa process R&D representative in company-wide lean sigma capa process improvement project.

  • Associate Director, Global Quality Management

    March 2003 --- February 2011
    leading a team of quality managers (qm), focused on a risk-based approach to ensure efficient and effective Quality Systems and gcp compliant best practice are employed by the clinical organization.. expanding the qm footprint from european to truly global by maximizing the matrix organization. expanding the qm responsibilities to include medical affairs support in regions were needed. conducting co-monitoring visits to identify and treat business risks. establish and maintain repository of country-specific Clinical Trial requirements. Due Diligence for local vendor selection. Trainer for the corporate 'standards of business conduct and Ethics' program.

  • Global Quality Manager, Central & Eastern Europe, Russia, Israel and Turkey

    September 2001 --- February 2003
    Expert counseling and Training in gcp and company procedures to Clinical staff. supporting local implementation of global processes and procedures, developing aligned local procedures, reflecting local/regional regulatory requirements. maintaining inspection-readiness, responding to audits and initiating process improvement. quality oversight of outsourced studies. regulatory vigilance.

  • GCP Compliance Auditor

    October 1995 --- August 2001
    bs en ISO 9001 lead Auditor, conducting audits of Clinical study sties in europe, south africa, and the middle east in various Therapeutic Areas. conducting internal system audits managing of the company's procedural document system. designing, delivering and managing Training of Clinical staff in gcp and procedural documents.

  • European Clinical Program Coordinator

    April 1994 --- September 1995
    designing and delivering Training of clinical staff in gcp, monitoring skills and procedural documents. european representative in the company's Clinical research Training coordination committee, standardizing and implementing a global monitor's Training program. publishing quality and project-related newsletters. supporting development and implementation of processes and procedures.

  • Informatics Consultant, Trainee

    April 1988 --- August 1988

Personality

Self Assessment :
Analytical thinkingCritical thinkingFlexibilityInterest in knowledgeProblem solvingResult OrientedService orientedIndependence

Knowledge

Self Assessment :
AuditingBusiness Process ImprovementBusiness ProcessesCAPAClinical monitoringClinical operationsClinical researchClinical trial audits and inspectionsClinical trialsComplianceCompliance with regulationsContinuous ImprovementCross-functional team leadershipGood Clinical Practice (GCP)ICH guidelinesInformed Consent ProcessKnowledge of the drug development processMicrosoft OfficePhases of clinical development (phase I to IV)Problem SolvingProcess improvementQA complianceQuality Assurance (QA)Quality AuditingQuality Management System (QMS)Regulatory RequirementsRisk ManagementRoot Cause Analysis (RCA)
LinkedIn Assessment :
ICH-GCPCAPARisk ManagementClinical researchRoot Cause AnalysisCollaborative Problem SolvingProcess improvementProcedural DocumentationAuditingTrainingInformation MappingSOP developmentClinical trialsMatrix LeadershipStaff Development

Skills and Expertise

Self Assessment :
Write documentsWork cross-functionallyWork collaboratively with the other members of the clinical research team Verify dataUnderstand protocolsTrain StaffSupport due diligence assessmentsSolve problemsReport serious adverse events (SAE)Quality control processProvide trainingProvide input to process improvement initiativesPrepare internal auditsPrepare external auditsPlan work to meet objectives and deadlinesOrganise meetingsOral presentationObserve trends in dataManage Quality Management System (QMS) documentationMaintain Quality Management System (QMS) Analytical skills Analyze data Create SOPs Monitor a clinical study Use content management systemsAdjust processes and methodsAdverse event reportingApprove suitability of patient information and consent documentsAssess quality process issuesAssist with site trainingAttend investigator meetingAttend seminarsAttend seminars, courses and meetings within and outside the companyCoach and provide guidance to clinical staff.Coach clinical staffComplete case report form (CRF)Create SOPsCreate standard operating procedure (SOP)Develop Quality Risk Management (QRM) initiativesDevelop training materialsEthics committee submissionsFollow-up of external auditsFollow-up of internal auditsFollow-up of quality assurance activitiesFollow-up of Quality Management System (QMS) processesIdentify risksImplement Quality Management System (QMS)Liaise with professionals in other divisions of the company as requiredManage risksTrain off site staffTrain on site staff

Education

  • Master's degree in physiotherapy from University of Leuven in 1985

Languages

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

Work Preferences

  • Work From Home:
    Yes, 2 to 5 days per week
  • Work Regime:
    Permanent position :    80% FTE
    BrightOwl employee :    80% FTE
  • International:
    Yes

Area / Region

Leuven, Belgium

Others

Driving License
  • Yes

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