Global Data Manager Specialist at Janssen Pharmaceutica • Accountable for project management, complete oversight and timely delivery of clinical trial data and documentation according to agreed upon timelines and quality expectations • Liaison between the trial customer, the CRO(s) and other functional partners(s) for all issues related to data for assigned trial(s) • Ensures Inspection Readiness of all data management deliverables and ensures adequate archiving of data management documentation• Member of Study Management Team and Clinical Working Group(s) and leading trial subteam(s)/workstream(s) for data management deliverables (e.g., eCRF design, Database Lock)• Mentoring new hires on Data Management activities.

Global Clinical Data Manager at Janssen Pharmaceutica assigned by Kelly Services Outsourcing and Consulting Group

NV Organon (until 2007), Schering-Plough (2007-2009), Merck Sharp & Dohme (2009 onwards)• Working in multidisciplinary teams to set up Electronic Data Capture (EDC) clinical study databases, reviewing the study protocol, creating for each study electronic Case Report Form (eCRF) specifications to build the database.• Providing data entry instructions to the sites on how to enter the clinical study data. • Preparing study specific Investigator Meeting (IM) materials on a variety of studies and presenting training on the IM. • Defining a clear overview of all data checks, partly being programmed into the EDC databases. Testing of EDC databases and programmed data checks.• Coordinating and supervising in good collaboration outsourced and internal ongoing data review activities to ensure overall integrity and consistency of the clinical study data (including all external data e.g. IVRS, ECG, Lab data, PK/ PD data, Cognition and Diary data). • Acting as primary contact for questions and issues regarding ongoing data review and query management. • Organizing the availability on crucial moments of all international cross-functional partners participating in data review and database lock resulting in a smooth ongoing process and database lock.• Acting as study project manager, identifying project risks, suggesting mitigations and periodically reviewing performance metrics resulting in the adherence to project timelines.• Participating in international multidisciplinary study teams always finding solutions to issues in good collaboration with the team and in compliance with company, ICH_GCP and Agencies regulations. • Documenting processes and issues in a Data Management Plan and archiving essential documents in the Trial Master File (TMF).• Mentoring new hires and less experienced colleagues on Data Management activities.Chaired information meetings on implementation of new processes after the first merger which was highly appreciated by my colleagues.

• Reconciled product registration documents available in the Product Registration Database (Demeter) with documents available in the local registration dossiers.• Brought the data in Demeter up to date in line with the reconciliation findings.

• Responsible for data management activities for more than 20 paper studies in phase I-IV.• Reviewed Clinical Protocol and Case Report Forms (CRFs) to ensure consistency and contributed to the CRF design.• Defined data validation checks (electronic and manual) and tested the programmed checks. • Used Clinical Trial Management Systems (CTMS) (Oracle Clinical, ClinTrial) for ongoing review of the data (including external data), finalized and locked the CTMS databases according to the agreed timelines.• Created the standard Data Validation Directives and as CDM Subject Matter Expert provided input in the development of standard and standardized CRFs resulting in faster start-up of studies.• Developed and maintained process documentation (Standard Operating Procedure (SOP)) on Data Validation process.• Participated in non-compound projects to improve systems and/or procedures e.g. Time Compression Initiatives.• Acted as Contract Research Organization (CRO) Coordinator for Data Management. Reviewed CRO bids; Chaired CRO Data Management meetings; Developed and maintained sponsor CRO manual on processes to be followed. These activities resulted in clarity for CROs of the sponsor requirements and increased data quality delivered by the CROs.• Coordinated and supervised data management activities performed by CROs.

• Participated in the development of monoclonal antibodies. • Produced tissue culture CMV antigen for diagnostic tests.• Participated in the development of coccidiose (chicken virus) diagnostic test.

WHO center for Influenza, Medical Faculty, Erasmus University Rotterdam• Participated in the development of influenza neuraminidase test.• Performed serologic testing to collect specific information regarding circulating strains and subtypes of influenza viruses.