Jennifer Eberhardt Email & Phone Number

Cambridge, Ma, Us

Cambridge, Ma, Us

Cambridge, Ma, Us

Cambridge, Ma, Us

Cambridge, Ma, Us

Cambridge, Ma, Us

Provide leadership, subject matter expertise, and strategy to drive clinical development inspection readiness activities, planning, and coordination. Collaborate cross-functionality to drive best practices, create tools, implement lessons learned, and improve future capabilities that overall, enhance the effectiveness of compliant clinical trial execution and real-time inspection readiness.

Tokyo, Jp

Provide oversight of Clinical Documentation Team to ensure effective support for CDO studies consistent with outsourcing strategies as defined by CDO. Develops plans to ensure effective CDT resourcing across all studies to support CDO document management activities, including staff recruitment and departmental training. Ensures consistency with CDT support and compliance across projects. Represents CDT in CDO preferred vendor partnership interactions related to clinical document deliverables. Responsible for maintaining collaborative relationships with external vendors to ensure the highest quality deliverables according to strategic plans. Provides support to CDT Managers to ensure assigned departmental objectives are met. Assists with the decision-making process, issue escalation and resolution supporting effective flow of information between internal and external customers related to document management issues. Participates in CDT Leadership meetings responsible for successful operational conduct of the CDT. In support of Global Clinical Operational Excellence strategies, develop and implement clinical document processes, to enhance support and compliance for CDO studies. Contributes to CDO’s inspection readiness through monitoring compliance of clinical document management and representing CDT in regulatory inspection and internal audit of clinical studies. Represents CDO in the preparation and execution of regulatory inspection and internal audits of Shire’s TMF documents, supporting efficient and compliant documents are delivered within required timelines. Monitors CDT compliance with new and current regulatory process and Shire policy. Monitors inspection readiness for clinical document management deliverables globally and provides support to CDT where necessary. Contributes to development and corrective and preventative actions.

Tokyo, Jp, Jp

Responsible for Clinical Document Management Specialist (CDMS) global activities ensuring effective resource and skills are available to support all CDMS aspects from development of the file structure through final archiving, ensuring compliance with regulatory guidances across all studies, including inspection readiness. Responsible for CDMS activities across all studies direct reports are assigned to, co-ordinating effective communication between team and Associate Director, Clinical Document Management. Develops strategies to ensure effective outsourcing of document management activities and compliance with new legislation. Partners with other Clinical Document Managers to ensure processes are being implemented in a global manner, where appropriate. With a focus on inspection readiness, monitors compliance with company process and industry regulations. Leads designated clinical activities in preparation for regulatory inspections and audits. Act as CDM project Lead and subject matter expert to support complex programs

Tokyo, Jp, Jp

Tokyo, Jp, Jp

New York, New York, Us

CRA/Monitoring dept, Clinical R&D - Women’s Health, Clinical Operations

Education record

Education record