Experience

Actelion (now Janssen Pulmonary Hypertension)

• Switzerland
• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Clinical Data Scientist

  • Apr 2016 - Present

  Field: Clinical trials phase III in rare diseases (multiple sclerosis, pulmonary arterial hypertension) Main tasks: ° Clinical trial data management from study start to database lock: EDC database requirements design and validation, Data consistency review, External data reconciliation, Summary reports and listings review ° Clinical trial documentation writing and/or review (protocol, listing and data transfer specifications, guidelines...) ° Protocol deviations management expert: reference for the clinical team and the CRAs regarding any issue related to protocol deviations and subjects’ safety, categorization and coding of all protocol deviations ° Protocol deviations quality control team lead ° Trial lead advisor for tasks allocation improvement ° Training of CRAs ° Coaching of newly hired clinical data scientists Show less



Business & Decision Life Sciences

• Belgium
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Project manager - Data Integration Specialist

  • Aug 2014 - Mar 2016

  1. Project manager: Field: Phase II trials in Oncology Main tasks: ° Technical and financial aspects, timing and resources planning ° Project team management ° Clinical trial data management from study start to database lock: CRF design and instructions creation, EDC database requirements design and validation, Data consistency review, Safety and External data reconciliation, Summary reports and listings generation ° Protocols review 2. Data Integration Specialist Field: eCRFs definition of based on SDTM – CDASH standards Main tasks: ° Data standardization and annotation of Modules/CRFs as per CDASH and SDTM standards for various therapeutic areas (Virology, Oncology, Infectious Diseases, Neurology…) ° Standard Data Validation Rules, Completion Guidelines and Implementation instructions linked to Data Collection Modules development ° Data collection import and updates in metadata platform (SDD) ° Database mapping specifications development for SDTM datasets generation ° Metadata libraries compliant with CDISC standards development and maintenance, including Data collection modules, metadata for tabulation datasets, standard data and metadata conformance checks Show less



Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Data Coordinator

  • Jul 2010 - Mar 2014

  Field: Clinical trials phases II-III in immunology (meningitis vaccines) Main tasks: ° Realization and coordination of all tasks related to clinical trials database set-up, interim analysis and final lock: CRF design and instructions creation, EDC database requirements design and validation, Data collection consistency, Safety and External data reconciliation, Summary reports and listings specification and analysis ° Protocols review ° Data Management Plan and trial workbooks completion ° Coordination of tasks with biostatisticians, programmers and clinical team ° Training of CRAs ° Oversight of delegated tasks Show less



Boston Scientific

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Clinical Data manager

  • 2009 - 2010

  Field: Clinical trials for cardiovascular devices evaluation (pacemakers and stents): Main tasks: ° Data management support for clinical team: review and evaluation of clinical cases, Summary reports and listings generation and analysis, safety data Reconciliation ° Clinical trial databases validation ° Data collection consistency Field: Clinical trials for cardiovascular devices evaluation (pacemakers and stents): Main tasks: ° Data management support for clinical team: review and evaluation of clinical cases, Summary reports and listings generation and analysis, safety data Reconciliation ° Clinical trial databases validation ° Data collection consistency



Institut Jules Bordet

• Belgium
• Hospitals and Health Care
• 500 - 600 Employee

• Clinical Data Manager

  • 2007 - 2009

  Field: Clinical trials phase II-III in oncology (breast and lung cancers, treatment of metastases…) Main tasks: ° Realization and coordination of all tasks related to clinical trials database set-up, interim analysis and final lock : CRF design and instructions creation, EDC database requirements design and validation, Data collection consistency, Safety data reconciliation, Summary reports and listings specification and analysis ° Administrative follow-up of clinical trials ° Oncological multi-disciplinary consultations preparation and follow-up Show less