Patsy Benson Email & Phone Number

2500 Valby, Dk

2500 Valby, Dk

• Serving as the Team Lead for External Data Management activities and vendor management across trials• Providing input to trial design and protocols for external data collection and integration• the data collection strategy for 3rd party vendor generated test results, championing consistency across programs and alignment with analysis and reporting/exploratory research needs of the trial.• Leading the standardization of data type specifications to ensure external data transfers to meet EDC requirements, data transfer with CDASH and SDTM requirements, and with the trial analysis and reporting needs.• Creating and maintaining data transfer specifications requirements, ensuring data are compatible with the clinical database and SDTM requirements to support data integration, analysis and reporting. • Ensuring external data study set up and processes promotes collaboration, alignment and consistency across trials, CROs and vendors. • Providing oversight of external vendors and external partners (e.g. laboratories, eCOA providers, technology providers, etc.) performing testing or data collection services Investigating and resolving issues with external data transfers.• Liaising with 3rd party vendors and central labs. • Performing Sponsor oversight of External DM vendors trial conduct using key performance indicators; performing oversight of data quality using key risk indicators and oversight dashboards.• Continuously identifying and mitigating trial related risks. • Liaising with 3rd party vendors and central labs. • Reviewing External Data Management vendor work orders and ensuring budget for External Data Management related activities• Process improvements: SOP writing, new systems implementation, defining data management best practices, global standards governance, etc.

Lawrence Township, Nj, Us

• Driving the data collection strategy for vendor generated test results, championing consistency across programs and therapeutic areas including SDTM/CDISC responsibilities • Serving as the subject matter expert for the setup of external vendors at the study level, managing the completion of study start up, amendment and post final changes.• Creating data transfer specifications, ensuring vendor data are compatible with the clinical database and SDTM requirements to support data integration, analysis and reporting.• Identifying and resolving issues which may negatively impact study deliverables. Escalating issues to leadership as needed.• Contributing to the development and application of smart systems and optimal approaches to support the collection of data.• Actively participating in and/or leading continuous improvement activities, defining and implementing the changes required to create an industry‐leading electronic data capture capability.• Liaising with and reviewing work delivered by external partners (e.g. laboratories, eCOA providers, technology providers, etc.) performing testing or data collection services on behalf of BMS.• Developing strong and productive working relationships with key stakeholders throughout the organization with the ability to think strategically across a broad portfolio and effectively express his/her views to senior management.• Representing the company in interactions with key external partners as part of any committee or industry group.• Study set up in Medidata Rave, Oracle Clinical, and Clinical Data Workbench to support data collection.• Study set up including collaboration across internal and external forums with study teams, CROs and vendors.• Influential leadership responsibilities to engage, manage, develop, and inspire a geographically diverse team.

Princeton, Nj, Us

Represent all aspects of Clinical Data Management (CDM) in a study team environment. Provide advice and solutions to CDM related issuesCRF design and review of other study planning documents if needed, including specifications for central and bioanalytical lab setupCoordinate review of Data Management Plan, Edit Check Specifications and other CDM related planning documentsCoordinate the setup of study database, edit check programming and data access browserLiaise with external data vendor and CROs for CDM related activities, including vendor qualification, budget/contract review and CDM deliverablesFollow up on CDM milestone and timelines. Ensure CDM quality and deliveryResponsible for study level data collection, data review, query management, medical coding, quality control, change management, external data reconciliation and SAE reconciliationCoordinate database lock and archival of CDM deliverables and documents