Anna A. Email & Phone Number

East Montpelier, Vt, Us

Somerville, Massachusetts, Us

-Communicates with study teams to compile user requirements for cross functional data review, study metrics, and manual checks-Produces tabular clinical data outputs and interactive graphic visualizations for clinical data management and clinical development reviewers-Collaborates with clinical study leads to develop exception and reconciliation outputs for external data-Maintains program data specifications and outputs based on customer feedback, changes to external data files, and updates to study protocol-Anticipates potential issues utilizing a broad programming perspective and troubleshoots complex clinical data output programs-Hosts new-user orientation sessions to acquaint staff with data review system and output request processes

Somerville, Massachusetts, Us

Somerville, Massachusetts, Us

Somerville, Massachusetts, Us

Somerville, Massachusetts, Us

-Execute routine tasks, such as metrics generations and CDM study documentation management-Assist with listing review, and query management according to SOPs, WIs, and study specific plans-Assist with data review for accuracy, completeness, and consistency-Assist with User Acceptance Testing for clinical study databases-Assist with development and review of eCRF Completion Guidelines-Assist with documentation in support of cross-functional data review-Contribute to SAE reconciliation process-Review clinical study documentation including clinical protocols, DMPs, meeting minutes, memos and study notes to file

Somerville, Massachusetts, Us

-Assists with selected data management tasks in support of clinical studies-Generates site performance metrics and distributes them to the cross-functional study teams-Assists with filing study documentation according to SOPs and Work Instructions and helps with QC of study files for completeness and accuracy-Assists with data report QC-Track Clinical DM Quality Documents Initiative and ensure Work Instruction development follows timeline

-Used electronic data capture system Medidata RAVE to download and organize patient surgical procedure reports, ensuring that protected health information (PHI) was appropriately redacted-Ensured that Investigational Product for a Phase 3 Clinical Trial was properly stored at clinical site pharmacies by reviewing freezer temperature logs and documenting temperature excursions-Tracked and filed study training documents for clinical site staff -Organized the company’s references using reference management software EndNote

-Assisted front desk, answered phone calls, processed new members, assisted in member inquiries-Maintained a clean and safe environment for members

-Organized and tracked SOP/ study specific training documents for Clinical Research Associates working on two clinical trials -Accessed an Electronic Data Capture System to download and organize patient data; ensuring that patient data was appropriately redacted-Tracked Principal Investigator 1572s for 3 clinical trials; crossed checked Investigators against the FDA Debarment Lists

-Assisted a Certified Canine Rehabilitation practitioner during client evaluations-Prepared equipment for exercises based on client’s needs-Independently worked with clients and owners during appointments-Assisted with front desk tasks