Experience

CROMSOURCE - A ClinChoice Company

• Italy
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Clinical Data Associate II

  • Aug 2015 - Present

  My responsibilities: Set up the Data Management Plan, Including the Data Validation Plan Perform data management duties as indicated withing the data management plan, guarantering its exact execution Conducts in-house data management process, including: in-house review, data coding, discrepancy management to ensure appropriate quality of data management deliverable within agreed timelines Designs, review and produce CRFs if needed, in order to facilitate the collection of data as required in the clinical trial protocol Creates or assists in the setup of the clinical trial database within the clinical data management system (CDMS) Sets up and maintains study specific Data Management Environments Assists in database locking procedures to ensure its compliance with procedures Show less



Actelion (now Janssen Pulmonary Hypertension)

• Switzerland
• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Trial Data Scientist

  • 2008 - 2013

  As a Trial Data Scientist my main responsibilities was to lead the team and maintain an oversight of the study(ies) I worked on. To ensure clinical development activities were adhered to the SOPs and applicable regulations. I made sure to meet study timelines that I and the clinical team had set. Dealing with any study issues and resolving the problem with the new action plan. Writing all the study data management documents covering specifications for external data transfer, data cleaning and review tools that was provided for the programmers for development for the allocated studies. Predicting future resourcing, providing weekly updates to department heads and to present study related topics at clinical meetings Show less



Quanticate

• United Kingdom
• Research Services
• 100 - 200 Employee

• Clinical Data Coordinator

  • Jun 2007 - Jul 2008

  My main responsibilities was to assist in the setting up of a database, testing and performing validations, writing pass and fail data and to assist in the preparation of study specific documentation as appropriate. Reconciliation of Serious Adverse Events with client safety database as appropriate. To maintain and track CRFs and queries. To resolve self-evident queries/allowable changes in the study specific database, to track and resolve data clarification forms in the study specific database, quality control of data entry and CRF/database as appropriate. Show less



IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Clinical Data Coordinator

  • May 2005 - May 2007

  As a member of Data Management my main duties was writing, testing and performing validations,setting up of pass and fail data deciding what listings were needed, discrepancy management, quality control procedures and setting up of Study Master Folder. To interact with the rest of the Clinical Data Management team to negotiate timelines and responsibilities with the project manager and other departments involved in the study. I provided regular updates to the DM team, Client and Sites. The department was made redundant in the year of 2007. Show less