Simon Clawson Email & Phone Number

London, Gb

Sutton, United Kingdom

InferMed Macro (Elsevier) – electronic data capture (EDC) clinical data management system Training new staff members in the use of the system for data management tasksManaging user accounts in the system management moduleAssisting and reviewing database specification prior to database build by ITTesting databases produced by IT prior to release Testing upgrades to the system JReview (Integrated Clinical Systems, Inc) – clinical data review system Training staff members in the use of the system to produce report specificationAssisting trial teams with specifying reportsTrouble shooting and investigating new functionality Producing test scripts and testing system upgrades and patches

Comprehensive Clinical Trials Unit At Ucl

Managing a phase III trial in Antiphospholipid syndrome.• developed data compliance reporting system• produced metadata for production of the trial databases• developed of a project plan for the trial • developing the trial protocol • developing the trial patient information and consent sheets• presented a trial update at the APS group meeting• unit level work on standard operating procedures (SOPs) • trained site staff in the trial processes, GCP, randomisation and database system

Contractor for Key People working for Amgen UK Uxbridge as a senior associate on the investigator sponsored studies (ISS) in the haematology oncology portfolio.• ensuring compliance with the ISS SOP• facilitating product teams in the approval process of ISS studies• communicating comments from product teams to the local teams and investigators• documenting the approval process time-points in the ISS database

Managed a phase III double-blind placebo trial in Small Cell Lung Cancer with a target of 860 patients. This involves:• ensuring trial compliance with all relevant UK legislation, including Statutory Instrument 2004, and good clinical practice;• processing and assessing Serious Adverse Events, as well as evaluating and reporting confirmed, suspected and unexpected Serious Adverse Reactions to the MHRA;• verifying clinical data for accuracy, monitoring against source documentation and reporting discrepancies to data managers;• producing and submitting proposed trial amendments to the MHRA and MREC for approval;• providing troubleshooting advice and support to the site team eg research nurses and pharmacists on all issues relating to the running of the trial from patient eligibility to recording of trial data; and• responding to questions from and supervising my designated data manager.A number of my initiatives have been implemented as best practice within the organisation, including streamlining the processes for each of:• Randomisation – I implemented a system for automating fax notifications in Microsoft Access. This saved the organization 5 minutes per patient (ie 72 hours for 860 patients);• Discrepancy reporting – I designed and produced a data discrepancy reporting system, which was linked to the clinical data management system, Macro. This allowed discrepancy reports to be produced from a centralised location, significantly reducing errors and ultimately allowing us to increase patient reports-per-hour six-fold; and• Others – including a system for the automatic generation of reports for the chief investigator’s causality assessment of SAEs; and annual safety reporting via a database, which I developed specifically for this purpose.

Product LicensingDocument management: Used sentinel (in-house programme) and Documentum to archive the CTD (common technical document) for drug licensing.

Worked on phase II (128 Patients) and phase III (1,000 patients) CR UK funded international trials; some trials in collaboration with the EORTC, British National Lymphoma Investigation and the Australasian Leukaemia & Lymphoma Group (ALLG). I was involved in the start up, maintenance and close down stages.Developed databases in COMPACT - configurable flat-file database on DOS.Query production, export and import into MS Access including production of data import specification and Macros to automate this process.

2:1, Biochemistry

Education record