Miceli
Director of Document Management at Advanced Clinical | Las Vegas, Nevada, United States
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As the Director of Document Management at Advanced Clinical, Miceli brings nearly two decades of specialized experience in managing the Trial Master File (TMF), a critical component in ensuring the integrity and compliance of clinical trials. In this role, Miceli oversees a dedicated team, guiding them in the meticulous organization and maintenance of TMF documentation, which is essential for regulatory compliance and successful trial outcomes. His expertise in Good Clinical Practice (GCP) and Standard Operating Procedures (SOP) ensures that all documentation meets the highest quality standards, thereby facilitating seamless inspections and audits.
Miceli’s involvement with the TMF Reference Model Steering Committee underscores his commitment to advancing industry standards and best practices. His previous roles on the Change Control Board and as the TMF RM Zone Team Liaison have equipped him with a comprehensive understanding of the complexities involved in document management within the pharmaceutical industry. This breadth of experience allows him to effectively participate in business development opportunities, where he contributes to project scope and budget activities, ensuring that TMF processes are both efficient and compliant.
In addition to his supervisory responsibilities, Miceli actively monitors key performance indicators related to TMF management, utilizing data-driven insights to enhance operational efficiency. His proficiency in Clinical Trial Management Systems (CTMS) and Electronic Data Capture (EDC) further supports his ability to drive continuous improvement initiatives. With a focus on oncology trials and a commitment to maintaining TMF inspection readiness, Miceli is a pivotal figure in advancing Advanced Clinical’s mission to deliver high-quality clinical research solutions.
Director of Document Management at Advanced Clinical in April 2021 to Present
Associate Director of Document Management at Advanced Clinical in September 2018 to April 2021
Associate Director, Clinical Document Management at Shire Pharmaceuticals in January 2015 to August 2018
Records Analyst (Contract) at Sunovion Pharmaceuticals in October 2014 to January 2015
Senior Manager, Clinical Documentation at Vertex Pharmaceuticals in January 2014 to July 2014
Manager, Clinical Development Business Operations at Millennium Pharmaceuticals in February 2004 to August 2013
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CTMS
Clinical Development
TMF
Clinical Data Management
Records Management
Process Management
Regulatory Documentation
GCP
Safety
SOP development
Business Process Improvement
eTMF
Archival Management
21 CFR Part 11
Regulatory Submissions
CRO
Management
Pharmaceutical Industry
Clinical Trials
Biotechnology
Clinical Research
FDA
Oncology
Drug Development
SOP
EDC
Clinical Trial Management System (CTMS)
Standard Operating Procedure (SOP)
CRO Management
Electronic Data Capture (EDC)
Good Clinical Practice (GCP)
U.S. Food and Drug Administration (FDA)
Veeva Vault
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Discover more about Advanced ClinicalWhat is Miceli email address?
Email Miceli at [email protected], [email protected] and [email protected]. This email is the most updated Miceli's email found in 2026.
What is Miceli phone number?
Miceli phone number is 7814927522.
How to contact Miceli?
To contact Miceli send an email to [email protected], [email protected] or [email protected]. If you want to call Miceli try calling on 7814927522. (updated on February 15, 2024)
What company does Miceli work for?
Miceli works for Advanced Clinical
What is Miceli's role at Advanced Clinical?
Miceli is Director of Document Management
What industry does Miceli work in?
Miceli works in the Pharmaceuticals industry.
Miceli Email Addresses
Miceli Phone Numbers
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