Erin Thompson Email & Phone Number

Toronto, Ontario, CA

• Act as the primary contact person for communication and discussion DM topics.
• Perform data management tasks (writing database design specifications, UAT plans, and data transfer specifications.
• Review data, issue queries, and resolve queries from various data sources.
• Perform third party vendor data management activities.
• Plan, manage, and perform data management activities for projects in compliance with trial Sponsors’ requirements.
• Accurately and efficiently validate electronically captured data.

Morrisville, NC, US

• Job title updated from Principal Data Manager to Principal Data Scientist. There is no change in responsibilities, thus all responsibilities listed under Principal Data Manager are still applicable.
• Trains team members for participates in Proposal Defence and Capabilities presentations
• EDC systems: DataLabs, Medrio, Medidata Rave

Morrisville, NC, US

• Coordinates & acts as point of contact for all data operations responsibilities related to data management for multiple studies when designated as the Data Management (DM) Team Leader for the project team
• Prepares DM plans, data entry guidelines, DM reports and other documents required for preparing and completing databases
• Reviews draft protocols and CRFs for potential data collection and representation, database structure or data entry problems, and provides feedback to the project team
• Reviews CRFs, data listings, and database to ensure all captured data follow the rules outlined by the protocol and DM 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.
• Reviews responses to queries for appropriateness, resolves any discrepancies and modifies the database accordingly

Morrisville, NC, US

• Job title updated from Associate Principal Data Coordinator to Associate Principal Data Manager. There is no change in responsibilities, thus all responsibilities listed under Associate Principal Data Coordinator are.

Morrisville, NC, US

• Provides coaching, support and mentoring to less experienced team members in data management practices and related technical issues.
• Coordinates and acts as point of contact for all data operations responsibilities related to data management for multiple studies.
• Prepares data management plans, data entry guidelines, data management reports and other documents required for preparing and completing databases.
• Reviews draft protocols and CRFs for potential data collection and representation, database structure or data entry problems and provides feedback to the project team.
• Tracks CRFs as they are processed through the Data Management department.
• Reviews CRFs, data listings, and database to ensure all captured data follow the rules outlined by the protocol and data management plan.

Morrisville, NC, US

• Accountable for all data management activities.
• Assisted in the development and implementation of new standards.
• Ensured data management project plan details are consistent with program level plans and milestones.
• Mitigated/arbitrated technical and process issues between outsourced partners.
• Ensured that the data management plan and cleaning strategy are consistent across the program.
• Served as point of contact for internal and external audits.

Morrisville, NC, US

• Responsible for the tracking of Safety database updates and the reconciliation of Safety Data including discrepancy tracking and query resolution during pre- and post-database lock.
• Researched and resolved issues pertaining to project requirements.
• Generated listings from the safety and project databases and performs comparison of pre-identified fields
• Maintained reconciliation spreadsheet (including the documentation of acceptable discrepancies) per protocol
• Issued queries for any discrepancies found during review in accordance with Global DM documentation
• Resolved queries in accordance with Global DM documentation

Morrisville, NC, US

• Responsible for the tracking of Safety database updates and the reconciliation of Safety Data including discrepancy tracking and query resolution during pre- and post-database lock.
• Researched and resolved issues pertaining to project requirements.
• Generated listings from the safety and project databases and performs comparison of pre-identified fields
• Maintained reconciliation spreadsheet (including the documentation of acceptable discrepancies) per protocol
• Issued queries for any discrepancies found during review in accordance with Global DM documentation
• Resolved queries in accordance with Global DM documentation

Morrisville, NC, US

• Performed medical coding using WHO Drug and MedDRA dictionaries within Oracle Clinical/TMS (Thesaurus Management System) for multiple clients
• Ensured consistency of coding across projects and raised concerns to the supervisor for resolution
• Trained on and followed Sponsor’s Standard Operating Procedures
• Provided consistent and accurate coding using standardized dictionary terminologies
• Proactively negotiated, planned, and managed project outcomes to established timelines

Los Angeles, CA, US

• Performed all aspects of clinical data management including: development of data validation specifications and data entry guidelines, database validation, CRF review, discrepancy management, listing review, conducted.
• Developed and delivered data management training (including process training) for data entry staff, data managers, and CRAs (new to the industry and experienced).
• Coordinated with CRAs, investigators and internal departments to resolve process, data and other trial specific issues.
• Designed CRFs, wrote corresponding CRF completion guidelines and maintained CRF Library.
• Reviewed and edited departmental Standard Operating Procedures (SOP) and Working Practice Documents (WPD).
• Coordinated with database programming manager and internal departments to standardize database programming reports, annotations, and database design.

Los Angeles, CA, US

• Performed all aspects of clinical data management including: development of data validation specifications and data entry guidelines, database validation, CRF review, discrepancy management, listing review, conducted.
• Developed and delivered data management training (including process training) for data entry staff, data managers, and CRAs (new to the industry and experienced).
• Coordinated with CRAs, investigators and internal departments to resolve process, data and other trial specific issues.
• Designed CRFs, wrote corresponding CRF completion guidelines and maintained CRF Library.
• Coordinated with department manager to standardize edit checks and various data management tasks and to develop departmental policies and procedures.
• Coordinated with department manager and internal departments to develop Oracle Clinical RDC-PDF training for internal departments and investigator sites.

Los Angeles, CA, US

• Performed all aspects of clinical data management including: development of data validation specifications and data entry guidelines, database validation, CRF review, discrepancy management, listing review, conducted.
• Developed and delivered data management training (including process training) for data entry staff (new to the industry and experienced).
• Coordinated with CRAs, investigators and internal departments to resolve process, data and other trial specific issues.
• Designed CRFs, wrote corresponding CRF completion guidelines and maintained CRF Library.

Los Angeles, CA, US

• Performed all aspects of clinical data management including: development of data validation specifications and data entry guidelines, database validation, CRF review, discrepancy management, listing review, and AE.
• Designed CRFs and wrote corresponding CRF completion guidelines.
• Performed first and second data entry from CRFs into the Oracle Clinical database.

Buies Creek, NC, US

• Planned syllabus for Data Management course that consisted of 16 weeks of weekly, 2 hour telecast lectures for Master and Bachelor degree students.
• Conducted all course lectures on the following aspects of data management: protocol design, CRF development, data validation, composing edit checks, paper-based and electronic clinical trials, electronic data imports.
• Created in-class exercises to reinforce lecture topics, including a team project of CRF design and edit check creation from an assigned protocol.

Buies Creek, NC, US

• Developed Excel grade book for course directors;
• Conducted course review sessions; Graded quizzes and tests;
• Maintained communication with Course Directors;
• Assisted students with projects and questions regarding course and degree program;
• Mentored students on academic and career opportunities
• Data Management Fall Semester 2004

Wilmington, NC, US

• Completed 2-week CRA training course
• Held full responsibilities of full-time regular CRA I during six month internship
• Conducted file audits
• Resolved queries for Phase III trial
• Maintained site contact
• Reviewed patient data on CRFs and in clinical database

• Completed CRFs
• Conducted patient visits
• Assisted with completion of regulatory documents
• Attended site initiation visits
• Maintained communication with sponsor and monitor regarding current study status
• Communicated with doctors regarding studies

Master'S Of Science, Clinical Research

Bachelor'S Of Science, Clinical Research

High School Diploma, High School/Secondary Diplomas And Certificates