Michelle Alton

114 Glen Valley Road Phone: (215) 295-4599

Yardley, PA 19067 Cell: (267) 252-9800
Email: MAlton55@comcast.net

Profile
Senior Clinical Operations Professional looking for full-time/contract management position, either in
Pharma/Biotech Clinical Development or with a CRO or other Service Partner. The ideal position would utilize the
skills listed below and my extensive experience covering the full spectrum of Clinical Operations from Clinical
Project Management, Outsourcing Management, Data Management, and eSubmissions and driving clinical projects
successfully to fruition, on time, on budget, and with the highest quality. I also bring to the table a strong track
record in leadership, mentoring, and development of staff, very effective oral/written communication and
collaboration skills, as well as a well-developed instinct for issue avoidance.
Skills

• Outsourcing and Vendor Management • Special Project Management

• Project Management
• Organization & Communication
• Staff Management & Mentoring
• Strategic Planning & Organizational
Leadership
• Focus on Quality, Timelines, Budget
• Process Reengineering & Change
Management
• Data Management Oversight
• Issue Avoidance and Resolution
• Talent Management
• Customer Relationship Management
• Policy & Procedure Development
• Document Authoring and Review
• Empathy, Measured Good Humor
• Familiarity with System Lifecycle
Management
• Systems Project Management

Responsibilities and Accomplishments

Cardiokine, Inc., Philadelphia, PA 2010 to 2010

Director, Project Management

• 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 minimize their impact

• Provided project support to the Company’s drug development activities particularly regarding those in
preparation for submission of the Regulatory Dossier for Cardiokine’s NDA candidate.

• Oversaw the activities of various support vendors.

Savient Pharmaceuticals, Inc., East Brunswick, NJ 2001 to 2009
Senior Director Clinical Performance & Data Management: 2006 to 2009

High profile director charged with controlling daily activities that were essential to ensuring clinical research
programs were functioning at maximum capability; entailed searching for appropriate vendors, and verifying vendor
work for quality, timeliness, and budget milestones.

• Key Management member of the team that planned and oversaw all Clinical Operations aspects of the
Company’s clinical programs
• Forged, managed, and nurtured strategic alliances with multiple clinical research related vendors that were
instrumental to the fulfillment of high quality, on-time eSubmission to FDA of a BLA. Led collaborations with
vendor partners, and closely oversaw their activities in support of our quality and timeliness goals. Directed
Data Management activities for Clinical Research trials, and played a key role in assuring the quality of
regulatory submissions from the Clinical Research point of view.
• Spearheaded the cross-functional electronic submission program for a registration dossier from initiation to
completion that garnered immediate acceptance by FDA for all clinical data including the data from an
innovative visual imaging component.
• Researched, selected, introduced and rolled out to the entire company a standardized Web-based project
management system to provide Senior Management with easy access to information on key company projects.

Director Clinical Data Management 2001 to 2006

Essential director with full autonomy over restructuring a small department entailing the design and implementation
of technical training programs, developing 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.

• Assumed responsibility of Clinical Project Manager for a Phase II study program, which involved managing
CRO activities and all activities related to data aspects of the program.
• Led a senior level cross-functional committee assembled to recommend remedial measures to ensure regulatory
compliance and to implement a streamlined drug development process. In response to the team’s final report,
Senior Management made the decision to adopt a full outsourcing model for Clinical Operations.
• Orchestrated a combined training and implementation project designed to bring a loose grouping of
Programming and Data-related functions into compliance with Regulatory requirements for the submission of
data from Registration trials.
• Also responsible for :
- Developing position descriptions and career ladders
- Managing vendor relationships.
- Leading a team in developing a corporate eSubmission strategy, in light of the company’s decision to
outsource all clinical development work.
- Authoring and reviewing registration (and other) documents
- Developing SOPs
- Implementing new systems,
Bristol-Myers Squibb 1990 to 2001

Senior Manager Clinical Statistical Systems Department 1998 to 2001

• Responsible for in-house training programs in support of study management software, and for coordinating
the technical support for maintenance and enhancement of current and new computing applications.

• Orchestrated the design advancement of the ground-breaking “Study Management Tools,” a web-based
system utilized by the Clinical Development organization to track and report clinical operations metrics.
Similar systems subsequently became a worldwide Industry standard

• Handled the development project and global management of the BMS worldwide centralized registration
and randomization system, as well as all Clinical Systems-related projects including product enhancement
and other development projects.

• Managed the deployment to the Clinical organization of a major proprietary software application for ad hoc
reporting of clinical data, which included training more than 400 staff worldwide, and bringing about a
significant cultural change.

• Acted in key role on the implementation team of a new data base management system (Oracle Clinical),
with lead responsibility for Communications.

• Managed a small staff of Systems Developers.

• Prepared user documentation of various in-house systems applications.

Manager/Senior Manager Data Management Department 1990 to 1998

• Conceived, developed, and grew the Company’s first Database Design group.
• Supervised seven full-time professional employees, as well as two to four consultants.
• Managed the customization and development of a vendor-provided database management system that
subsequently became the central (standardized) DBMS for the combined three global sites comprising
Bristol-Myers Squibb Data Management.

Education
B.A. Psychology, Magna cum Laude Trenton State College

Graduate work in Statistics Rutgers University

Course work included “Interpretation of Data,” “Biostatistics, I and II,” “Design of Experiments,”
“Regression Analysis,” and “Theory of Statistics.”
Other

• Appointed to serve a two-year term on the Customer Advisory Board of the vendor for the Clinitrial®
Data Management System
• Currently do volunteer work as photographer for the Delaware County (Pennsylvania) SPCA and for the
local weekly newspaper

• Accomplished amateur photographer (www.maltonphotos.zenfolio.com), happy to shoot Company events.