Jeffrey Snavely

· Create and Distribute Reports on Clinical Study Data for assigned Clients/Studies

· Responsible for Creating, Maintaining, and Communicating our Data Reporting Schedule

· Responsible for Interaction with the Internal Project Managers to Coordinate and fulfill Request

· Ability to Extract Raw Data Files and Generate ad-hoc Reports from our various Data Sources (Oracle, Access, Labmatrix, and LabVantage) and be able to complete Technical Tasks. Work with Biorepository and Study Manager teams to ensure accuracy of Raw Data used to Generate Reports

· Responsible for Managing all the Data Edits. Define, Run and Review Edit Checks and Resolve Discrepant Data

· Act as point of reference for internal and external clients on handling of clinical trial data

· Participate in the creation of data management SOPs as needed.

· Develop data transfer metrics for review by management

· Escalate potential risks or issues to appropriate management or team members

· Create and Distribute Reports on Clinical Study Data for assigned Clients/Studies

· Responsible for Creating, Maintaining, and Communicating our Data Reporting Schedule

· Responsible for Interaction with the Internal Project Managers to Coordinate and fulfill Request

· Ability to Extract Raw Data Files and Generate ad-hoc Reports from our various Data Sources (Oracle, Access, Labmatrix, and LabVantage) and be able to complete Technical Tasks. Work with Biorepository and Study Manager teams to ensure accuracy of Raw Data used to Generate Reports

· Responsible for Managing all the Data Edits. Define, Run and Review Edit Checks and Resolve Discrepant Data

· Act as point of reference for internal and external clients on handling of clinical trial data

· Participate in the creation of data management SOPs as needed.

· Develop data transfer metrics for review by management

· Escalate potential risks or issues to appropriate management or team members

· Reviews all documentation for sample accessioning for compliance to internal SOP’s and ensures documentation accuracy. Confirms all client agreed upon key data points are present.

· Reviews all data edits performed during sample accessioning for accuracy

· Communicates with the appropriate Project Manager regarding any study-related issues that may affect turn-around-times and assists with study management as needed.

· Assists QA in archiving duties including filing of laboratory and study documentation as needed.

· Assists as needed in reviewing various types of documentation from other functional departments at CGI-RTP for accuracy and completeness, including equipment logs, maintenance logs, calibration logs, purification paperwork, and laboratory inventory.

· Communicates directly with clients or clinical sites, as applicable, via reach-outs regarding any issues or discrepancies in sample receiving and accession data review.

· Compiles quality metrics related to performance in client reach-outs, sample resolutions, and other data/documentation.

· Identifies trending issues and communicates these findings with management and study-responsible Project Manager.

· Supports CGI-RTP laboratories with various regulatory compliance and assessments.

· Assists in the writing, editing, and implementing of standard operating procedures, material requirements documents, and other essential documentation.

· Assists with all areas of Quality Control and ensures that Quality & Integrity of documentation is maintained throughout the assigned departments

· Reviews all documentation for sample accessioning for compliance to internal SOP’s and ensures documentation accuracy. Confirms all client agreed upon key data points are present and study specific exceptions were followed.

· Compiles and tracks study specific issues and reports findings to Project Manager

· Tracks quality issues found during the QC process and report findings to Director of Quality Control

· Identifies critical quality issues within a department and notifies the Director of Quality Control

· Release barcode labels into production

· Prioritizes resources and materials in support of project activities

· Reviews all data edits for accuracy

· Communicates with the appropriate Project Manager regarding any issues that may affect TAT

· Assists in the writing, editing, and implementing of standard operating procedures, material requirements documents, and other essential documentation.

· Reviews all paperwork related to sample accessioning for documentation accuracy and ensures all Client agreed upon key data points are present.

· Communicates directly with clients regarding any issues or discrepancies in sample receiving in conjunction with the appropriate Analytical Project Manager until completion.

· Identifies trending issues and communicates these findings with the Senior Manager, Sample Management Quality Control and the appropriate Analytical Project Manager.

· Assists the Senior Manager, Sample Management Quality Control in ensuring quality control of large biorepository-based projects or transfers.

· Assists the Senior Manager, Sample Management Quality Control in the compilation of data and metrics related to performance in Sample Management and Quality review.

· Assists in the writing, editing, and implementing of standard operating procedures, material requirements documents, and other essential documentation.

· Collaborates with IT and data management in review and cleaning of data prior to client data transfers.

· Tracks time associated with certain client reach-out tasks as necessary for client billing.

· Assists in accessioning operations as necessary to maintain adequate coverage for workload.