Alice Scouller

Experience

• 

  PPD

  Aug 2008 - May 2009

  Clinical Data Associate

  Clinical Data Associate responsible for: - Reviewing data - Query resolution - Helping to meet team targets and goals set

• 

  Actelion

  Jun 2009 - Jan 2018

  - Core member of Clinical Trial Team- Designing CRF and clinical database based on Protocol Review- Authoring key Data Management documents- Successful lock and closure of five clinical studies- Key contact for external vendors and the set-up of data transfer- Protocol Deviation review - Lead SAE Reconciliation with Global Drug Safety - Inspection training - Responsible for maintenance DM section of the Trial Master File - Data cleaning activities on multiple studies- Review of data listings- Ensuring high data quality in line with ICH/GCP guidelines - Adhering to study timelines provided - Supporting study team to achieve set milestones- Providing data reports

  • Trial Data Scientist

    Mar 2012 - Jan 2018

  • Data Scientist

    Jun 2009 - Mar 2012
• 

  The Janssen Pharmaceutical Companies of Johnson & Johnson

  Jan 2018 - now

  - Currently responsible for four clinical studies under two high profile portfolios- Extensive knowledge of database build in Medidata RAVE, eCRF design and validation - Key contributor in the production of final study SDTM and review of CSR- Primary point of contact for external vendors. - CRO Oversight- Experienced in the collection of Local Laboratory data, study specific parameter mapping and conversion to SI unit- Quality Control of all Data Management activities- Authoring of Data Management documents and providing contribution to other trial related documents in adherence to company specific and regulatory guidelines - Leading Serious Adverse Event (SAE) Reconciliation - Defining Protocol Deviation review- Author and maintenance of vTMF- Represented Data management in both FDA/ EMEA inspections leading to successful marketing authorization of new drugs. Show less

  • Senior Global Data Manager

    Jan 2021 - now

  • Global Data Manager

    Jan 2018 - Jan 2021