Allround Clinical Research Professional, versed in data management, site management, project management with a focus on quality and regulations
Senior Clinical Quality Associate Diegem, Machelen, Belgium
Since February 2015
- Clinical Study Support
- Act as a reviewer of protocols, informed consent forms, case report forms and other essential study documentation for product and process changes, offer overall support to project teams in order to eliminate compliance risks.
- Represents Clinical Quality at project / protocol deviation meetings to maintain and promote quality and compliance within CR. Ensure the protocol deviation management is aligned globally, for all trials.
- Clinical Regulatory Support
- Coordinator role to obtain, interpret and communicate regulatory requirements.
- Serves as a liaison between CR and Regulatory and QA.
- Clinical Study Support
Clinical Project Manager (CPM) Diegem, Machelen, Belgium
July 2012 --- January 2015
• Provides project management expertise throughout the development and implementation of clinical studies. Interacts with various study support groups and the business unit in order to assist in clinical strategy, the development of study plans, and project deliverables. • Facilitates communication between R&D, Regulatory Affairs, Sales and Marketing, Training, Senior Management and investigational sites by conducting team meetings, drafting and sending routine correspondence (e.g., newsletters) and by presenting regular updates to mgmt staff. • Facilitates site selection process by conducting meetings with appropriate departments and individuals to review and revise draft site list as necessary, and by communicating the final site list to team members. • Manages clinical study timelines, budget by utilizing the appropriate project management tools, selecting providers, managing vendor contracts and ensuring expenditures are within budgetary guidelines. • Identify resource needs and elevates/resolves resource constraints with mgmt. • Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process. • Facilitates the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback/direction. • Provides input to protocol design, case report form design, data management plan, monitoring plan. • Organizes Steering Committee meetings and communication; Coordinates investigator and research coordinator meetings. • Oversees compliance to study requirements; Reviews compliance to protocol and elevates critical protocol deviations; Reviews monitoring reports. • Provides study-specific training to internal team members and site personnel.
Clinical Research Associate (CRA) Diegem, Machelen, Belgium
July 2010 --- December 2012
Support a number of investigational sites to conduct company initiated clinical research in the cardiovascular field (Cardiac Therapies and Vascular Solutions). Ensure that the trial at the site level is conducted, recorded and reported in accordance with the clinical investigational plan, SOP’s and applicable regulatory requirements.
June 2007 --- June 2010
• Coordinate distribution of information related to incoming study requests to the approval committee members • Organize collection of documents and forms related to incoming requests and communicate with requestor to obtain the outstanding information/forms • Keep track of the work of KOL’s in interventional cardiology and endovascular interventions • Follow-up on approved projects regarding enrollment, budget, publication
June 2007 --- June 2010
• Preparation, processing, follow-up, and filing of research projects submitted to ISS Review Committee for review • Maintain and co-ordinates the ISS review process according to procedures and policies • Act as a pivotal point of contact for incomplete submissions and follow-up of the projects • Set-up and maintenance global web-based tracking tool for ISS, act as expert
Clinical Research Data Administrator
October 2005 --- June 2007
• Keeping monitors, managers and customers updated about the status • Working together with internal and external partners to resolve issues • Clean patient data via vertical listings and manual review • Working together with Science team, statistics team, business aplication team, ... to build e-CRF’s, determine the needs for the corelab, … • Prepare the Clinical Events Committee • Providing training in the e-CRF system to GDT/ABT-employees and third parties • Writing of a Data Management Plan • Keeping records of data management issues, finding solutions and share with the involved people • Assist in the Protocol Deviation Committee • Make sure the various providers are working and integrating each others data • Discuss with other teams the needs for results, so the timelines can be set up • Franchises: Drug Eluting Stents, Bio-Absorbable Stents
Clinical Data Coordinator
January 2005 --- January 2006
• Reviewing Case Report Form data for clarity and inconsistencies via programmed checks and listings • Generating, sending and processing of queries • Contacts with site managers (CRA's) and trial managers, Clinical team • Follow-up of the outstanding collection portions and DCF's • Validating edit checks • Experience in Phase 1 and Phase 2-3 trials • Franchises: Pain and Antipsychotics
Clinical Research Data Administrotor
January 2005 --- January 2006
• Maintaining the imaging material tracking database • Tracking all material (e-CRF's, imaging material, signatures, ...) • Keeping monitors, managers and customers (corelab) updated about the status • Working together with corelab to resolve issues • Opening, processing and closing queries in the e-CRF (working together with monitors) • Make sure the data are clean, by vertical listings and e-CRF review • Working together with other teams to build e-CRF's, determine the needs for the corelab, ... • Prepare all material for the Clinical Events Committee, and make sure they are dealing with it • Providing training in the e-CRF system to colleagues and third parties • Writing of a Data Management Plan, and implementing it • Keeping records of data management issues, finding solutions and share with the involved people • Assist in the Protocol Deviation Committee with data management tasks • Writing and tracking note to files • Make sure the various providers are working and integrating each others data (InForm, ICON, corelab, ...) • Discuss with other teams the needs for results, so the timelines can be set up • Franchises: Drug Eluting Stents, Bio-Absorbable Stents
Clinical Data Coordinator
April 2005 --- October 2005
• Reviewing Case Report Form data for clarity and inconsistencies via programmed checks and listings • Generating, sending and processing of queries • Contacts with site managers (CRA’s) and trial managers, Clinical team • Follow-up of the outstanding collection portions and DCF’s • Validating edit checks • Experience in Phase 1 and Phase 2-3 trials • Franchises: Pain and Antipsychotics
Attention to detailCoordinationInterest in knowledgeSelf-confidenceSelf-disciplineService orientedCollaborationCritical thinkingEfficiencyFlexibilityIndependenceOptimismOrganizationProactivityPerspectiveResiliency
R&D Medical devices Negotiation Phase IAllergy and immunologyCAPACardiologyCardiovascular diseasesClinical Data Management (CDM)Clinical DevelopmentClinical monitoringClinical researchClinical operationsClinical Study DesignClinical trial audits and inspectionsClinical trial budgetingClinical trial managementClinical trialsCommunication SkillsCross-functional team leadershipCTMSContract negotiationData ManagementData cleaningEDCEfficacy trialsElectronic Data Capture (EDC) Emergency medicineEnglishFDAEMAEarly development stageGCPGood Clinical Practice (GCP)ICH GCP guidelinesICH-GCPINDInformed Consent ProcessKOL managementMicrosoft ExcelMicrosoft OfficeMedical DevicesMedical ImagingLegal Considerations: Contracts and IndemnityMitigationNegotiationNew Drug Application (NDA)Patient Follow UpPatient Screening and RecruitmentPhases of clinical development (phase I to IV)PowerPointPrinciples and ethics of clinical researchProcess improvementMonitoring Study ProgressWriting Study Procedures and SOPsPreclinical regulations and practicesScreen patientsStrategic PlanningProject ManagementProtocolProblem-solving methods and troubleshootingRandomization and blindingRegulatory affairsRegulatory StrategiesUnderstanding of regulatory guidelinesRegulatory RequirementsRegulatory submissionsQuality Assurance (QA)Quality of Life (QoL) outcomesSOPTime Management
Skills and Expertise
Build and manage the Trial Master File (TMF) Create SOPs Develop clinical trial protocols Develop protocols Interact with nurses Interact with physicians Monitor a clinical study Search literature on clinical trialsAdjust processes and methodsAdverse event reportingApprove monitoring reports Assure medical qualityAssist study siteApprove patient informationApprove consent documentsCollaborate with principal investigatorbudgeting of R&D activitiesCalculate trial timelinesConduct close-out visits Use content management systemsDesign subject consent formEnsure data consistencyIndentify clinicians to conduct clinical trialsInformed consent processManage subject consent formQuality control processReview quality control activitiesFollow-up of quality assurance activitiesFollow-up of Quality Management System (QMS) processesMaintain Quality Management System (QMS)Manage Quality Management System (QMS) documentationSet-up quality policiesCalculate process efficiencyCollaborate with project teamControl protocol versionsConfirm protocol complianceNegotiate protocol details Review study protocolsConduct monitor visitsReview monitoring reportsSchedule sponsor monitoring visitsFacilitate sponsor monitoring visitsSupervise clinical monitorsSite managementProtocol management
CCIR in Interventional Cardiology from TECC in 2010
Master in Biomedical Sciences from Universiteit Antwerpen in 2004
Bachelor in Biomedical Sciences from Universiteit Hasselt in 2002
Training and Certification
GCP auditing in 2015 Certification