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. • Validate and disseminate metric reports to Sponsor and internal team members.• Review EDC edit check specifications for assigned studies. • Perform training on the EDC system, dataflow, and QC processes to clinical trial personnel.• Participate in project kick off meetings, investigators meetings, and project management team meetings.• Perform study-level resource planning and management.• Manage the process of database modifications.• Develop and maintain the DMP. • Assist in development and implementation of clinical data standards, training standards, project management, and data management technologies.• Develop and maintain the DQRP, coordinate with programmers to complete the programming and validation of the listings and summary tables as specified.• Perform project tracking and maintain project milestones and timelines. • Promote effective project management practices. • Participate in and contribute to departmental initiatives.• Define and monitor data flow and QC processes in accordance with corporate SOPs, GWP, and departmental guidelines.• Provide training on data entry, data review, data flow, and QC processes.• Assist QA with audits.• Ensure project team maintains and prepares final archival of data management documentation.• EDC Systems: Medidata Rave, Flatiron Vessel

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 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 Defense and Capabilities presentations • Tracks CRFs as they are processed through the Data Management department • Quality control reviews output of the clinical database (entry screens or data listings) against primary documents (e.g., data management plan, case report forms and queries) for data accuracy, consistency and application of predetermined conventions • Assists in writing quality control reports in a timely and concise manner according to Standard Operating Procedures

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 still applicable.

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.• Generates paper and electronic queries to appropriate internal or external personnel 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.• Performs quality control reviews of the clinical database against primary documents for data accuracy, consistency and application of predetermined conventions.• Assists in writing quality control reports.• Reviews & contributes to the development/update of department SOP’s and Working Guidelines.• Leads/participates in task force groups that impact the team.• Participates in project costing estimates and proposal review in the business development/change order process.• Participates in Proposal Defense and Capabilities presentations

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. • Ensured data flow across the program is within projected timelines. • Ensured consistency in review and quality of safety data across the program. • Reviewed data quality audit outputs to identify trends across the program to ensure quality data. • Reviewed metrics and monitor performance against targets.

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 • Tracked pending safety database updates and communicates with team as appropriate • Assisted in management of reconciliation request and provides updates at regular intervals • Managed internal QC process for studies, as needed • Performed final reconciliation before database lock and uses for any analysis and reporting, as necessary • Followed up on any outstanding issues post database lock and provides updates to the team.• Updated final reconciliation spreadsheet post database lock after all outstanding issues have been resolved • Trained and followed sponsor’s Standard Operating Procedures as applicable • Liaised with the sponsor as needed to resolve issues that cannot be resolved within the organization • Assisted in the research and resolution of issues pertaining to project requirements • Mentored and trained less experienced team members in data management practices and related technical issues.

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 • Tracked pending safety database updates and communicates with team as appropriate • Assisted in management of reconciliation request and provides updates at regular intervals • Managed internal QC process for studies, as needed • Performed final reconciliation before database lock and uses for any analysis and reporting, as necessary • Followed up on any outstanding issues post database lock and provides updates to the team.• Updated final reconciliation spreadsheet post database lock after all outstanding issues have been resolved • Trained and followed sponsor’s Standard Operating Procedures as applicable • Liaised with the sponsor as needed to resolve issues that cannot be resolved within the organization • Assisted in the research and resolution of issues pertaining to project requirements

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 database audits, AE (MedDRA) and drug (WHODrug) coding, and locking of clinical trials database for transfer to biostatistics. •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).•Designed CRFs, wrote corresponding CRF completion guidelines and maintained CRF Library. •Coordinated with database programming manager and internal departments to standardize database programming reports, annotations, and database design.•Coordinated with programming department to create local laboratory range database for data management.•Coordinated with department manager and internal departments to develop Oracle Clinical RDC-Classic training for internal departments and investigator sites. •Created, edited, and produced training videos for Oracle Clinical RDC-Classic for distribution to the investigative sites and conducted web-based training for sites and internal personnel.•Managed RDC documentation updates and versioning of forms, manuals, and guides.•Managed Helpdesk; assisted internal and external RDC users with study specific issues, software installation, and technical troubleshooting.

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 database audits, AE (MedDRA) and drug (WHODrug) coding, and locking of clinical trials database for transfer to biostatistics. •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. •Mentored and trained Campbell University Clinical Research Bachelor of Science candidate during Data Management internship.

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 database audits, AE (MedDRA) and drug (WHODrug) coding, and locking of clinical trials database for transfer to biostatistics. •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 (MedDRA) and drug (WHODrug) coding. •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, coding, study close-out, and achieving career goals.•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• Regulatory Affairs Spring Semesters 2005-Spring 2006

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• Generated queries• Obtained laboratory certifications• Performed phone close outs of sites

• 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• Marketed company to Sponsors and CROs• Performed data entry

Master'S Of Science, Clinical Research

Bachelor'S Of Science, Clinical Research

High School Diploma, High School/Secondary Diplomas And Certificates