Early Development Lead (Business Analyst): MSD, Jul 2011 – now
• Data management role committed to exploratory and phase I trials with a key role during study start up, conduct phase and database lock
• Cooperating closely with CRAs and clinical scientists to e.g. review clinical protocols, monitor progress of clinical activities, monitor data quality, prepare and deliver site training
• Linking business to IT by defining data base and data management specifications based on business needs and clinical protocols; including developing new standards/study specifics where needed
• Organizing (study team) meetings and act as chair
• Delivering valid and confirmed data within the set timelines working closely with sites, CRAs and the clinical team, for database lock and interims like dose escalation meetings or decision meetings
• Ensuring study documentation is reliable and timely archived to the trial master file
• Delivering study specific training to clinical site personnel, investigators and CRAs
Safety Data Specialist: MSD, Jan 2011 - Jun 2011
• Pharmacovigilance role processing spontaneous case reports and clinical study case reports on drugs and devices
• Performing case intake, processing and follow-up taking reporting timelines into account

Laboratory Coordinator: N.V. Organon (Currently MSD), Apr 2007 – Dec 2010
• Data management specialization coordinating data flows from lab, ePRO, ECG and clinical genetics vendors for multi-centre, international trials as well as phase 0/1 trials
• Maintaining lab data management system containing lab reference and lab safety ranges
• Vendor qualification, monitoring of data quality delivered by vendors and resolution of issues
• Delivering ´scope of work´, data formats and data transfer timelines working with vendor, statisticians and clinical team
• Designing data formats, programming data loads and actual loading of electronic data sets
• Coordinating loading schedules of the e-data transfer team located in Japan, the Netherlands and USA
• Maintaining SOPs and guidance documents, contributing to process improvements, delivering peer support in day-to-day work
• Train e-data transfer team on use of systems, updated SOPs and guidance documents

(Senior) Clinical Data Analyst: N.V. Organon (Currently MSD), Jan 2006 – Dec 2010
• Data management role working on multi-centre, international trials from start-up to database lock
• Designing clinical data collectors based on clinical protocols
• Writing data validation documentation and entry guidelines
• Providing instructions to sites and CRAs on how to complete (e)CRFs
• Coordinating and participating in multidisciplinary data review, issuing and resolving queries resulting in timely delivery of valid and confirmed data
• Providing site training during investigator meetings

Clinical Data Manager: CTO (currently Clinquest), Jun 2003 – Dec 2005
• All round data manager designing and programming clinical data collectors based on sponsor protocols
• Writing data validation documentation and entry guidelines, cleaning data accordingly issuing and resolving queries to timely deliver valid and confirmed data sets to sponsor
• Developing SOPs and giving SOP training to support validation and implementation of Oracle Clinical (OC), setting up OC global library following SDTM/CDISC standards
• Coding Adverse Events and Concomitant Medications using MedDRA and WHO Drug dictionaries
• Working closely with CRAs when data cleaning, performing co-monitoring visit