Experience

PRA Health Sciences
• United States
• Research Services
• 700 & Above Employee
• Lead Data Manager

  • Mar 2020 - Present


Premier Research

• United States
• Biotechnology Research
• 700 & Above Employee

• Associate Principal Data Manager

  • Sep 2017 - Mar 2020

  Coordinates and acts as point of contact for all data operations responsibilities related to data management for multiple studies when designated as the Data Management Team Leader for the Premier Research project team Prepares data management plans, data entry guidelines, data management reports and other documents required for preparing and completing databases, when requested Reviews draft protocols and CRFs for potential data collection and representation, database structure or data entry problems, and provides feedback to the project team, when requested Reviews CRFs, data listings, and database to ensure all captured data follow the rules outlined by the protocol and data management plan Generates paper and electronic queries to appropriate internal or external personnel (investigational sites, vendors, Clinical Research Associates (CRAs), client representatives) to resolve problematic data identified during every aspect of the data management process Reviews responses to queries for appropriateness, resolves any discrepancies and modifies the database accordingly Reconciles 3rd party data with CDMS data. Provides coaching, support and mentoring to less experienced team members in data management practices and related technical issues Reviews & contributes to the development/update of department SOP’s and Working Guidelines Leads/participates in task force groups that impact on the team Participates in project costing estimates and proposal review in the business development/change order process Participates in Proposal Defence and Capabilities presentations Tracks CRFs as they are processed through the Data Management department If assigned, interacts with the Biometrics Project Manager on a continual basis throughout the course of the study Coaches and provides day to day support to other team members. Show less



CRF Health

• United Kingdom
• IT Services and IT Consulting
• 1 - 100 Employee

• Project Manager

  • Feb 2015 - Dec 2015

  Overall project management, execution and coordination of the project team in providing electronic patient management (eDiaries) and wireless data solutions Developed, reviewed and approved project-related study documentation during the course of a Project Lifecycle Lead or participated in meetings with the client team Managed CRF Health’s relationship with customers as the primary customer contact for project- related issues Interpreted the relevant client materials to assess all possible project deliverables in addition to those identified during the sales phase of the study Worked closely with the Customer’s project leadership to achieve the study goals Maintained compliance to QMS (Quality Management System), adequate planning and resourcing, as well as budget oversight and forecasting Ensured that the Project Team maintained high quality service and on time delivery of data and project outputs for the customer Developed, reviewed and approved other project- related study documentation during the course for the Life Cycle Developed the project and validation plan paying specific attention to all project deliverables Conducted periodic status checkpoints with customers and teams to assess progress against the plan. Performed re-forecasts of project variables as necessary throughout the project Prepared and reviewed status reports on all project activities and issues as required Reviewed the project actual versus budget on a regular basis, identifying and creating Changes in Scope (CIS) as appropriate Utilized project management skills of communication, presentation, time management, organisation and planning to successfully implement company’s products Worked with Program Directors as needed to ensure consistency between projects with a single sponsor Maintained status using CRF Health internal systems Worked closely with the HEOR (Health Economics & Outcomes Research) team in addition to Programmers Show less



Mother Nature Science

• Entertainment
• 1 - 100 Employee

• Science Activity Instructor

  • Aug 2014 - Dec 2014

  Presented and facilitated hands-on, interactive science demonstrations to children of primary/pre-prep and prep school age Promoted fun, stimulating learning for children Demonstrated dynamic and inspirational qualities Presented and facilitated hands-on, interactive science demonstrations to children of primary/pre-prep and prep school age Promoted fun, stimulating learning for children Demonstrated dynamic and inspirational qualities



Roche

• Switzerland
• Biotechnology Research
• 700 & Above Employee

• Study Data Manager

  • May 2011 - Aug 2014

  Clinical trial Phase 2 & 3 studies have included Schizophrenia and Breast Cancer indications in both Electronic Data Capture (EDC) Rave and MACRO databases Successfully completed database Migrations following Protocol Amendments to phase 2 & 3 Type 2 Diabetes trialsInvolved in the database closure of a number of Rave studies simultaneously within a short timeframeParticipated in the oversight and prioritisation of work for Data Managers at Quintiles in Strasbourg and Profil in DusseldorfInfluenced and negotiated positive outcomes in order to meet specific requirements from various stakeholders Effectively communicated ideas, project goals and status of work and independently presented at departmental meetingsProvided input during protocol review to ensure Clinical Data Management (CDM) components were included and comprehensive Set targeted timeframes for deliverables along with risk plans as a contingency for any potential scenarios that may have created timeline delaysWelwyn Representative for the Global CDM SOP Working Group reviewing and revising SOPs Show less

• Associate Study Data Manager

  • Oct 2010 - Apr 2011

  Participated in the oversight and prioritisation of work for Data Managers at TCS in Mumbai Identified and developed solutions to complex problemsCreated and maintained CDM study documentation in line with protocol requirements Co-ordinated User Acceptance Testing for clinical database Actively participated in study debrief meetings at Study Management Team (SMT) level; shared learning with CDM staff and participated in subsequent best practice implementation Participated in Service Provider selection, evaluation and management, including reviewing and providing input to Scope of Work (SoW) Worked with the set up and maintenance of Medical Data Review tools such as PRS and J-Review.Experience with Generic Data Models (GDMs), Statistical Analysis Software (SAS) listings and Statistical Data Tabulation Model (SDTM) datasets.Handled and reconciled Biomarker data from various lab vendorsLiaised with specialist vendor for database specifications in adjudicating cardiac data Show less

• Data Manager

  • Jan 2008 - Sep 2010

  Performed discrepancy management for automated and manual queries in the Oracle Clinical (OC) databasePerformed Data Management (DM) activities in preparation for snapshots, interim analysis and database closuresRegularly reconciled various lab data from vendorsSuccessfully involved in the Pilot for integrated Science queries into the Oracle Clinical database

• Lab Data Manager

  • Sep 2006 - Dec 2007

  Received and facilitated the upload of central and local laboratory results using various different tools. Collaborated with labs and clinical teams to ensure completeness and accurate transmission of data during study set-up and conduct.Entered and applied laboratory assignment criteria to associate patient’s lab results in Roche database with the respective ranges from the lab.Appropriately raised discrepancies on lab data that were inaccurate.Covered Phase 2 & 3 clinical trials on a range of indications such as Rheumatoid Arthritis and Breast Cancer in addition to Paper and Electronic Data Capture (EDC) MACRO studies Show less