Kathy Powers Email & Phone Number

Boston, MA, US

Morrisville, NC, US

Boston, Massachusetts, US

• This is a short term contract in order to assist in the database lock process.
• Perform data management tasks for database lock for an electronic study
• Collaborate with a team of CDMs on the project to ensure all activities are carried out according to Standard Operating Procedures
• Generate and review data listings as needed.

Fridley, Minnesota, US

• Perform data management tasks from study start-up to database lock for both paper-based and electronic studies
• Collaborate to lead a team of CDMs on the project to ensure all contracted activities are carried out according to Standard Operating Procedures
• Monitor study activities to ensure they are done with the timelines and budget restrictions
• Perform SAE and vendor data reconciliation

Cambridge, MA, US

• Ensures OSM deliverables meet quality expectations and are delivered on time
• Provides technical input to projects with respect to standards challenges
• Participates on cross-functional teams to establish, implement and maintain clinical data standards for the Medical Division
• Participates in technical initiatives helping with user acceptance testing and developing use cases, test scripts and other SDLC components
• Supports the operations of the Clinical Standards Governance Committee
• Serves as subject matter expert and information resource on the clinical data standards library and business administration support on OSM owned technologies

Durham, North Carolina, US

• Independently perform all clinical data cleaning activities on assigned project
• Develop project specific guidelines, e.g. SAE handling, Data Management Plan
• Initiate the running of study specific programs
• Perform data management tasks from study start-up to database lock for both paper-based and electronic studies
• Collaborate to lead a team of CDMs on the project to ensure all contracted activities are carried out according to Standard Operating Procedures
• Monitor study activities to ensure they are done with the timelines and budget restrictions

• Perform data management tasks from study start-up to database lock for both paper-based and electronic studies
• Collaborate to lead a team of CDMs on the project to ensure all contracted activities are carried out according to Standard Operating Procedures
• Monitor study activities to ensure they are done with the timelines and budget restrictions
• Collaborate on the creation of CDISC standard documents for future studies
• Trained staff on performing newly implemented CDISC tasks
• Perform SAE and vendor data reconciliation

Responsible for start-up activities such as development of project forms to meet projectneeds; creation, review and finalization of case report forms; and database design andpreparation of data validation specifications. Additional responsibilities include pre-entrypreparation of forms for data entry, data review and discrepancy management, coding ofdata.

Responsible for performance of supportive tasks for the clinical data management ofclinical trial data, such as assistance in the design of Case Report Forms (CRF),preparation of the CRF for data entry, review of periodic data listings; QC of DataClarification Form (DCF) integration and additional QC activities including but not limitedto CRF audits..

Responsible for set up and maintenance of project specific tracking documentation andother supporting guidelines. Tracking and checking of received case report forms(CRFs) for accuracy. Initial and/or second data entry of CRF data into validatedrelational databases. Second data entry includes the resolving of discrepancies betweenthe two passes. Also, the.

Responsible for set up and maintenance of project specific tracking documentation and other supporting guidelines. Tracking and checking of received case report forms (CRFs) for accuracy. Initial data entry of CRF data into validated relational databases. Also, the maintenance of CRFs and other project specific files; performance of general clerical and.

US

Responsible for entering case forms into the database. Evaluating and directing tocorrect insurance group. Querying external sources for lost or incorrect information.