Project manager (pre-clinical) at J&J Beerse, Belgium
Since January 2016
The Senior Manager, PD&S Project Manager provides project management support to Pre-Clinical Development (PCD) Leaders and PCD teams. This includes:
• building project timelines
• developing and analyzing scenarios, risk assessment and mitigation planning
• developing project budgets
• developing resource needs (FTE’s = Full Time Equivalents) with PD&S functions
• tracking and reporting actualization of project timelines, budgets and FTE’s.
The Senior Manager, PD&S Project Manager provides support for continuous forecasting, quarterly financial updates, development of Business Plan Budgets and FTE’s and preparation for Governance Meetings.
He/she is a member of the PD&S team (sub team of Compound Development Team) and works with the team and with PD&S functions to facilitate successful project execution, achievement of key deliverables and of budget and FTE goals.
As a member of the Project Management Team he/she supports cross-functional planning, budgeting and resourcing activities.
The primary responsibilities include:
• be an active member of assigned PD&S Teams
• build and maintain project plans
• Develop forecasts regarding project resource needs (OOP’s and FTE’s)
• Track actual expenses and FTE’s against forecasts
• Liaise with project finance, program management and customer groups from Janssen R&D organization.
Clinical Safety Monitor Diegem, Machelen, Belgium
January 2012 --- November 2015
• Supervision of safety processes and AE handling for various clinical trials.
• Daily medical review of clinical trial adverse events (event causality, seriousness, device relationship); CRF review, source document request and review; Assemble & submit adverse events to CEC for adjudication; review of adjudication results.
• Main liaison between the different bodies involved in the safety process i.e. between the DSMB, CEC, CRO, and study team.
• Protocol review and formulation of case report forms, specifically with regards to reporting and management of adverse events.
• Regulatory reporting of clinical trial serious adverse events and device deficiencies.
• Support in preparation of periodic safety reports (to the ECs and the DSMB) and of the safety section of clinical study reports.
• Development, coordination and completion of clinical study safety training for all staff and CEC members involved with the clinical study.
• Training and QC of an external safety designee assigned to a specific study.
Safety compliance coordinator Diegem, Machelen, Belgium
July 2008 --- December 2011
• Coordination and support of all clinical research activities related to Clinical Event Committee (CEC) for multiple clinical trials within AV.
• Creation of narrative reports for notable clinical adverse events.
• Give support to sites with subject evaluation and protocol adherence in adverse event reporting.
• Daily review of clinical trial adverse events and participation in improving safety processes.
Associate Clinical Data Manager Beerse, Belgium
January 2008 --- June 2008
I provided efficient and strenuous support as a Data Manager to meet the tight timelines of projects.
Postdoctoral Researcher Anderlecht
August 2006 --- December 2007
Postdoctoral Researcher at Unibioscreen s.a., a specialist oncology drug discovery and development company.
I designed, planned and performed research experiments which showed capacities of analytical thinking, taking initiative and the ability to work both independently and as a team player. I also managed a laboratory assistant.
Attention to detailAdaptabilityInterest in knowledgeEfficiencyDiligenceCoordinationCollaborationAnalytical thinking
Clinical operationsGeneticsCancerCardiology Medical devicesICH-GCPBiotechnologyMolecular & Cellular Biologymolecular biologyResearchGood Clinical Practice (GCP)Clinical trialsClinicalClinical DevelopmentClinical Data Management (CDM)Clinical researchPharmaceutical IndustrySafety concerns (such as therapeutic ratio with respect to possible adverse effects)Cardiovascular diseasesDrug safety assessment
Skills and Expertise
Assure medical quality Control data Design case record forms Guide students Interact with physicians Monitor a clinical studyAdverse event reportingApprove queriesArchive documentationAssess adverse reactionsAssess subject safetyAttend investigator meetingAttend steering committeeCalculate trial timelinesClinical data collectionConduct research at universitiesData codingDocument adverse eventsEnsure data consistencyEthics committee submissionsGenerate regulatory submissions Interact with CROsManage clinical trial files/documentsManage subject safetyManuscript reviewParticipate in medical reviewRead medical literatureVerify dataWork under specific instructionsRegulatory submissionsReport non-compliance incidentsReport serious adverse events (SAE)Research at universitiesReview queriesReview study protocolsResolves queriesReview clinical study reportsSerious Adverse Event (SAE) ReconciliationTrain off site staffTrain on site staffUse western blotting techniqueWrite papers
Ph.D. in Biotechnology from Universiteit Gent in 2006
Master in Biotechnology from Universiteit Gent in 2001
Training and Certification
MS Project and Planisware in 2016 Training
GCP in 2015 Training
Good documentation practices in 2015 Training
Transcelerate modules (4 modules) - Risk based monitoring in 2015 Training
Insight in 2014 Training
ISO14155-2011 in 2014 Training
Training on firefighting and building evacuation in 2014 Training
Powerpoint in 2011 Training
email efficient use in 2010 Training
Project Management in 2010 Training
Excel 2007 in 2009 Training
MindMapping for professionals in 2009 Training
Coronary Basic & DES in 2008 Training
PRINCE2® Foundation Certificate in Project Management in 2016 Certification
Exercising Influence in 2014 Certification
Lean Six Sigma Yellow Belt in 2014 Certification
Professional and team development in 2012 Certification
Expert has 7 publications (Will be avalible with full profile)