Deborah Marshall
About Deborah Marshall
Deborah Marshall is a Clinical Trials Associate at Bristol-Myers Squibb with extensive experience in TMF processes and clinical trial administration.
Title
Deborah Marshall currently holds the position of Clinical Trials Associate at Bristol-Myers Squibb.
Company
Deborah Marshall currently works at Bristol-Myers Squibb, a global biopharmaceutical company. In her role as a Clinical Trials Associate, she plays a pivotal part in ensuring the effective management of clinical trials and the integrity of their documentation.
Background in Clinical Trials Administration
Deborah Marshall has an extensive background in clinical trials administration. She worked as a Senior Clinical Trials Administrator, contracted out by PAREXEL in London, United Kingdom for seven months from 2008 to 2009. Before this, she was employed with the same company as a Clinical Trials Administrator for two years from 2006 to 2008. Her tenure at these positions helped lay the foundation for her expertise in clinical trial processes.
Responsibilities at Bristol-Myers Squibb
At Bristol-Myers Squibb, Deborah Marshall is responsible for implementing and training effective Trial Master File (TMF) processes. She serves as a subject matter expert in TMF Operations, OSIF, eOSIF, SUSARs, and study start-up roadmap. She also has oversight of the eTMF/TMF review process and generates and analyzes metrics associated with these processes. Additionally, she trains and supports Clinical Trials Assistants (CTAs) in study filing and archiving. Deborah also maintains tracking tools and metric data, communicates compliance metrics with internal and external stakeholders, and handles requests for access to study systems.
Training and Mentorship
Deborah Marshall has played a significant role in training and mentoring the CTA team at Bristol-Myers Squibb. Her mentorship has contributed to the advancement of numerous team members to high-achieving roles within the company. She is regarded as an expert in handling MHRA audits and inspections, adding substantial value to the organization through her specialized skills.
Expertise in TMF Operations and Compliance
Deborah Marshall's expertise in TMF Operations includes managing the eTMF/TMF review process, training staff on effective TMF processes, and overseeing the generation and analysis of compliance metrics. Her role involves extensive interaction with both internal and external stakeholders, ensuring adherence to regulatory requirements and assisting with audits and inspections.