Katherine Taylor Email and Phone Number

This role champions Merck, Global Clinical Trial Operations ( GCTO’s) work in fostering a diverse, highly skilled clinical trial operations talent pool. The eSSC, located in the WeWorksoffice in Philadelphia, PA, recently celebrated its two-year anniversary; a key milestone of progress in our mission to deliver high-quality clinical trial support services with a skills-first, agile hiring approach. Building upon the successful foundation, the eSSC will now expand services to the full GCTO organization. The eSSC is one of the major contributors to ‘OneTen’ candidates enterprise wide. They play a significant role in helping us shape and cultivate the workforce of the future.

Execute an end to end strategy for furthering risk based quality management through advanced analytics. Building high performing team to execute the REAIM strategy.

Leads the implementation, delivery and all aspects of Adaptive Integrated Monitoring (AIM), Global Clinical Trial Operation’s continuous improvement initiative to further the organization’s risk- based quality management (RBQM) through advanced analytics.This includes development of central monitoring plans (CMPs) and clinical dataspecifications aligned with critical data, process and risk assessments. Ensures execution of central analytics and monitoring activities, including Quality Tolerance Limit analysis, Key Risk Indicator analysis and Central Statistical Analytics to support identification of important study issues that require monitoring, management and adaptation of study plans.

CAPA Management; QAAD v 8 Management, reporting and training; CQA SOP creation/revision; GCP Training

Independently prepare, conduct, report and follow-up on audits according to the CQ&C SOPs, the agreed audit strategy, audit program and objectives for project/study related audits, audits of processes/systems associated with clinical research and audits of CROs. Act as a Global Clinical Project representative for assigned projects. In liaison with management, represent the sponsor during clinical regulatory inspections including preparation, escorting inspectors and communication information about inspection processes and results. Facilitate inspection requests by interacting with key personnel.Provide training, mentoring and coaching to less experienced CQ&C staff members. QAAD Expert User for US Site. Support community of users in trouble shooting and resolution of activities effecting daily use of audit reporting tool.

Manage and independently conduct GCP (Good Clinical Practice) audits of SPRI sponsored clinical trials, including worldwide clinical investigator audits, internal audits, due diligence and other special audits and assessments as assigned. Communicate audit findings in writing to clients, their management and other responsible personnel. Evaluate adequacy and completeness of corrective/preventive action plans;Review audit reports prior to issuance to clients for accuracy and consistency. Provide guidance to auditors in communicating findings and recommendations. Evaluate audit findings for an assessment of effectiveness of the quality and compliance program applied for specific projects. Provide recommendations for increased effectiveness. Initiate/implement and routinely review and assess adequacy of departmental specific training materials, processes, and procedures. Participate in development of written procedures and guidelines for the unit and associated training; Manage creation/development/implementation of custom Access database for recording details (objective, scope and method, results, recommendations) of audits and Corrective and Preventive Action (CAPA). Create specific tools for audit conduct. Utilize database to identify compliance trends and system-related issues within client group project for periodic communication to management.Ensure departmental awareness of current internal (Clinical Research and Corporate Standard Operating Procedures) processes and external regulations (FDA Regulations, GCP/ICH); Participate on Clinical Research SOP Committee to ensure clinical research activities are in accordance with regulations/sponsor SOPs. Recommend future areas for audits to management.

Provided clinical data management expertise to Clinical Trial working Groups (CTWGs) for data collection and cleaning for Phase I and II Oncology trials; participate on Global Core Product Teams and CTWGs to understand business objectives and ensure the appropriate clinical data management support and responses are provided;Collaborated with statistical programmers and the data mapping team in developing data validation plan; recommend process and work flow solutions to augment the clinical capabilities in support of clinical trial initiatives;Managed and assessed working practice of CRO/external vendor (including Electronic Data Capture) Data Management Group and ensure that they are in compliance with GCP, Federal regulations as well as consistent with AstraZeneca internal Standard Operating Procedures; Participated in Clinical Data Management infrastructure and capability development, including the creation and implementation of standard processes and tools to ensure safety and clinical data are reconciled throughout trial execution as well as prior to clean file declaration;Managed the integrity of clinical information throughout trial execution reporting phases while maintaining awareness of advances in the field of Clinical Data Management.

Manage several protocols to meet the guidelines of Pfizer study close out procedures; performing various data management tasks for newer protocols housed in Oracle Clinical (V3.1.1) including database structure review and approval and edit check document development, review, and approval; Subject Matter Expert (SME) for domestic Pfizer studies within Anti-Infectives therapeutic area, with regard to discrepancy management and improving relationships with clinical team; Manage CROs, oversee timelines and deliverables to ensure efficient trial processes for multiple protocols; oversee in house Clinical Data Coordinators (CDCs) and provide recommendations for training needs to upper management as appropriate; Initiate and organize the approval and release of clinical trial databases; continually functioning as a liaison between clinical, programming, statistics and drug safety team members.