Michelle Alton

Michelle Alton Email and Phone Number

Photography Volunteer in the Communications Department @ American Red Cross, Southeastern Pennsylvania Chapter
Morrisville, PA, US
Michelle Alton's Location
Morrisville, Pennsylvania, United States, United States
Michelle Alton's Contact Details

Michelle Alton work email

Michelle Alton personal email

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About Michelle Alton

Connect with me on LinkedIn using malton55@comcast.net........................................................................................ All invitations to connect are welcome; No IDK. LION-------------------------------------------------------------------------------------You KNOW that outsourcing Clinical Operations tasks is necessary, and yet it is a challenge to work successfully with vendors . If you need successful collaborations with outsourced work, that is my specialty. You might connect with me because I have deep, extensive experience in Clinical Operations and a special talent for and interest in selecting and collaborating with Clinical Research service partners to assure high quality, on time, and on budget outcomes. Early on I realized that it is KEY for vendors and sponsors to work as PARTNERS and to feel as though their goals are perfectly aligned. I have had great success by demonstrating knowledge and experience, an open mind, willingness to work together on solutions, and expressing enthusiasm about the collaborations and respect for the team members' expertise adding value to the VP Clinical Operations.------------------------Read the story in my Profile to learn how I developed the expertise to help your drug development programs to produce high quality results, on time, and on budget. For more information, contact me at 267-252-9800.---Specialties: Collaborations of all sorts. My career began at the bottom of the ladder as an entry level Biostatistician, and I worked my way slowly to Sr. Director level, moving through data management, clinical systems project management, Outsourcing Management, and clinical project management. . Most of the success along the way resulted from strong collaborations with both in-house groups and outside vendor partners.

Michelle Alton's Current Company Details
American Red Cross, Southeastern Pennsylvania Chapter

American Red Cross, Southeastern Pennsylvania Chapter

View
Photography Volunteer in the Communications Department
Morrisville, PA, US
Website:
redcross.org
Employees:
32537
Michelle Alton Work Experience Details
  • American Red Cross, Southeastern Pennsylvania Chapter
    Photography Volunteer In The Communications Department
    American Red Cross, Southeastern Pennsylvania Chapter
    Morrisville, Pa, Us
  • American Red Cross, Southeastern Pennsylvania Chapter
    Photography Volunteer In The Communications Department
    American Red Cross, Southeastern Pennsylvania Chapter Sep 2012 - Present
    Greater Philadelphia Area
    Provide photography services for Chapter events, including fundraisers, the annual gala "Red Ball," press conferences, celebrations, and any other events requiring photography, including local disasters. Also do volunteer photography for other organizations such as Salvation Army, Multiple Sclerosis Society, and Autism Cares Foundation.
  • Your Best Shot Photography
    Freelance News, Sports, And Fine Art Photographer
    Your Best Shot Photography Oct 2010 - Present
    Philadelphia, Pennsylvania Area
  • Household Manager At Home
    Home Project Manager
    Household Manager At Home 1995 - 2014
  • Cardiokine, Inc.
    Director, Project Management
    Cardiokine, Inc. Mar 2010 - Sep 2010
    • Provided strategic recommendations to Senior Management on operational facets of the drug development process.• Leveraged depth of knowledge and experience in the drug development process to analyze or anticipate project issues and obstacles to minimize their impact• Provided project support to the Company’s drug development activities particularly those relating to preparation for submission of the Regulatory Dossier for Cardiokine’s NDA candidate.• Oversaw the activities of various support vendors
  • Savient Pharmaceuticals, Inc.
    Sr. Director, Clinical Performance & Data Management
    Savient Pharmaceuticals, Inc. Apr 2006 - Sep 2009
    High profile director charged with controlling daily activities essential to ensuring clinical research programs were functioning at maximum capability, which entailed searching for appropriate vendors, verifying vendor work for quality, timeliness, and budget milestones, contributing to writing and evaluating registration documents, and analyzing submission tables and text for accuracy and consistency. - Forged, managed, and nurtured strategic alliances with clinical research related vendors that were instrumental to the fulfillment of high quality, on-time eSubmission of a BLA to FDA.- Managed, from vendor selection to completion the successful collaboration with a key imaging lab, an innovative program that used digital photography to track the reduction/disappearance of gout tophi. The data and photographs from this program provided a key component to the approval of KRYSTEXXA.- Steered patient recruitment activities for phase 3 program in a rare orphan disease population, the outcome of which exceeded timeline expectations and translated into a $25M savings.- Introduced and rolled out to the company a standardized Web-based project management system that would furnish senior management with a “one-stop-shopping” vehicle to stay informed on key company projects.- Spearheaded the electronic submission program from initiation to completion of a BLA dossier that garnered immediate acceptance by FDA of all clinical data including the data from an innovative visual imaging component.
  • Savient Pharmaceuticals, Inc.
    Director, Data Management
    Savient Pharmaceuticals, Inc. Sep 2001 - Apr 2006
    Essential director with full autonomy over restructuring a small department entailing the design and implementation of technical training programs, writing job descriptions, constructing a career ladder, and incorporating processes that had significant impact on the regulatory aspects of data management workflow and the monitoring of clinical trials.- Superintended a cross-functional operational modernization committee assembled to ensure regulatory compliance and implementation of a streamlined drug development process.- Functioned as clinical project manager for a Phase II study program, which involved CRO activities and the direct management of all activities related to data aspects of the program.- Championed group and vendor activities that produced compliant and concise data for the KRYSTEXXA BLA that was submitted to FDA in October of 2008.
  • Bristol-Myers Squibb
    Sr. Manager, Clinical Systems
    Bristol-Myers Squibb 1998 - 2001
    Senior manager appointed to orchestrate the design advancement of “Study Management Tools,” a web-based system utilized by the clinical development organization to track and report clinical operations metrics. - Handled the global management of the BMS worldwide centralized registration and randomization system (BriQTone), as well as all clinical systems-related projects including product enhancement and development projects.- Conceptualized and instituted in-house training programs designed to support the Study Management software and arranged for the ongoing technical support for current and new computing applications, including training of the Help Desk technicians- Architected and sustained web pages that supported computing applications including Study Management Tools (an innovative system in the Pharmaceutical Industry that has been emulated worldwide in Clinical Development), BriQTone and Oracle Clinical. - Introduced a proprietary data reporting tool and customized the training that allowed physicians and researchers to query the clinical data bases for information simply and accurately instead of using a cumbersome process to make programming requests for required information.- Collaborated in the creation and maintenance of a customized (for BMS) Medical Coding Dictionary.
  • Bristol-Myers Squibb
    Sr. Manager, Data Management
    Bristol-Myers Squibb 1985 - 1998
    Up to 12 Direct ReportsQuickly promoted from Manager to Senior Manager of Data Management charged with developing the technical arm of the Data Management Organization. Primary focus was to guide group through the customization and development of a vendor-provided database management system initially to function in the Squibb Data Management environment, and subsequently (after the merger of Squibb with Bristol-Myers) to be the central (standardized) DBMS for the combined three global sites comprising Bristol-Myers Squibb Data Management. - Worked cohesively with management-level personnel across sites, led extensive collaboration with software engineers within the company’s Scientific Information Systems Department and built synergies between group and the product vendor, which led to the development of many beneficial services and training courses. - Led the tri-site team in the design and development of a system for data discrepancy management that became the prototype for Clintrial’s “Resolve” system, and later formed the basis for Oracle Clinical’s Enhanced Discrepancy Management System (EDMS). These systems and their competitors are in use worldwide in the Pharmaceutical industry.- Instrumental contributor in company’s efforts to streamline processes; played a central role in integrating and fostering the successful standardized use of the system at the three BMS sites (New Jersey Connecticut, Belgium).

Michelle Alton Skills

Cro Clinical Trials Pharmaceutical Industry Clinical Data Management Biotechnology Gcp Project Management Data Management Fda Clinical Research Strategic Planning Strategy Photography Sop Crm Regulatory Affairs Medical Affairs Protocol Biostatistics Regulatory Submissions Oncology Staff Development Edc 21 Cfr Part 11 Issue Sop Development Ind Pharmacovigilance Collaboration Document Preparation Employee Training Medical Writing Outsourcing And Vendor Management Mentoring Document Authoring Customer Relation Management Training Development Photo Editing Image Editing Therapeutic Areas Ich Gcp Oracle Clinical Infectious Diseases Clinical Study Design Empathy Issue Avoidance Staff Management System Lifecycle Management Computer System Validation

Michelle Alton Education Details

Frequently Asked Questions about Michelle Alton

What company does Michelle Alton work for?

Michelle Alton works for American Red Cross, Southeastern Pennsylvania Chapter

What is Michelle Alton's role at the current company?

Michelle Alton's current role is Photography Volunteer in the Communications Department.

What is Michelle Alton's email address?

Michelle Alton's email address is ma****@****ast.net

What schools did Michelle Alton attend?

Michelle Alton attended Rutgers University, Trenton State College.

What are some of Michelle Alton's interests?

Michelle Alton has interest in Patient Recruitment, Delaware County (Pa) Spca, Data Management, Issue Avoidance, Communication, The Princeton Festival, Director, Staff Management, Vendor Management, Pharma.

What skills is Michelle Alton known for?

Michelle Alton has skills like Cro, Clinical Trials, Pharmaceutical Industry, Clinical Data Management, Biotechnology, Gcp, Project Management, Data Management, Fda, Clinical Research, Strategic Planning, Strategy.

Who are Michelle Alton's colleagues?

Michelle Alton's colleagues are Linda Mcallister, Alonza Colvin, Sheila Winans, Ruth Taylor, Michele Lugo, Brenna Campbell, Theodore Baldwin Iii.

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