Key areas of Responsibility:• Administration of study sites, providing user access, assigning e-learning, trouble-shooting, problem-solving, auditing of sites and users in the Medidata Rave system for EDC, running reports• CDEx (Clinical Data Exchange: electronic archiving) and RMS (Records Management System: archiving paper documents and electronic media)• Providing pertinent support to Data Managers• QC activities (data checks/cleaning, sponsor CDs, etc.)• (Double) Data Entry (Oracle Clinical & Rave)• Designing paper CRFs• (Individual responsibility) Contributing to development and maintenance of SOPs and WPDs

Key areas of Responsibility:• Set-up and maintenance of essential documents for Trial Master File (TMF) for Phase I studies.• Compiling package of submission documents to regulatory authorities and ethics authorities• Liaising with Study Managers and CROs• Finalizing TMF and subsequent archiving. • Support Clinical Study Report preparation (e.g., drug lot or batch numbers, PI/clinical site and laboratory information, copies of references cited, narratives, PI or coordinating investigator signature)• Assist SMs and CRAs in study file reconciliation for close out visits• CDEx (electronic archiving)• Archiving in TRIM of paper documents and electronic media• (Individual responsibility) Responsible for the completion of ClinTrials.gov Disclosure forms for international publication.

Key areas of Responsibility:• Data entry and writing data entry instructions • Writing and executing data validation plans• Database testing• CRF design• Query writing/solving• Clinical/pharmaceutical study report writing (ICH9) assistant including medical coding according to MedDRa• Simple statistical analysis• (Serious) Adverse Event narrative writing• Setting up and maintaining clinical study files• Compiling and distributing study-related documentation• Reviewing/editing UK text• Archiving (electronically and manually) completed clinical study files and (confidential) study material• QA assistant, including writing and updating company SOPs• Taking minutes at study progress meetings