Global Lead CRAHome based
Since August 2007
Communication CRA team (internal & CRO), participate in selection vendors, Training/Coaching junior CRA's, development of Training tools + Presentations (international Investigator meeting/regular team meetings (webinar)), audit fu (capa), representative of monitoring team in project team.
development of study documents: science)" rel="nofollow">Protocol review, review of crf, icf, crf guidelines
development of recruitment Planning & monitoring guidelines
Communication CRA team (internal & CRO), participate in selection vendors, training/coaching junior CRA's, development of training tools + presentations (international investigator meeting/Regular team meetings (webinar)), audit FU (CAPA), representative of monitoring team in project team.
Development of study documents: Protocol review, review of CRF, ICF, CRF guidelines
Development of recruitment planning & monitoring guidelines
Clinical Project Manager (CPM) Home basedJune 2011 --- April 2014
Project Planning: lead kick off meeting(s), Communication CRA team (internal & CRO), lead medical team meetings, selection & negotiations vendors, vendor management, Training/Coaching junior CRA's (& Sales reps), development of Training tools + Presentations (international Investigator meeting/regular team meetings (webinar)), audit fu (capa)
Negotiation & review of trial budget and management.
co-monitoring visits CRA - quality & accompanied visits - part of quality plan
Clinical Project Manager (CPM) Brussels, BelgiumDecember 2009 --- October 2010
Clinical Project Manager (CPM) NielJune 2008 --- May 2009
Problem solvingAttention to detailCreative thinkingCollaboration
oncologyOphthalmologyPhase IIPhase IIIPhase IVPulmonary diseasesSupervising CRAsUrologyCardiovascular diseasesClinical researchClinical trial budgetingClinical trial managementContract negotiationCross-functional team leadershipCTMSDesigning case report formsDrug regulatory authoritiesEfficacy trialsElectronic Data Capture (EDC) Ethics submission and approval processFDAICH-GCPInformed Consent ProcessNeurological surgery
Skills and Expertise
Design case record forms Monitor a clinical studyAssess site feasibilityCalculate trial timelinesCoach clinical staffCollaborate with project teamCommunicate with investigatorcoordinating research projectsCreate clinical documentsDesign subject consent formEthics committee submissionsInteract with CROsInteract with ethics committeeManage projects resourcesSupervise clinical monitorsSelect investigatorsReview vendor reportsReview study protocolsReview monitoring reportsRespond to audit findingsRegulatory submissionsProvide trainingPresent data at congressOrganise meetingsManage vendor budgetsManage study budget