Summary
Overview
Work History
Education
Skills
Presentations
Timeline
Generic

ASHLEY SACCHETTI

Chalfont

Summary

Dedicated and reliable project manager with six years experience in the pharmaceutical sector. Skilled in efficiently overseeing intricate clinical trial studies from protocol inception through successful implementation and final database lock.

Overview

6
6
years of professional experience

Work History

Clinical Data Management Project Manager

Accenture
10.2020 - Current

• Manage 15-20 Phase I and II clinical trial studies from kick-off and Go-Live to maintenance until final database lock is achieved.
• Increasing department success by implementing over 100 change requests into In-Life studies and by completing Go-Lives of at least 4 new builds.

• Develop project plans, facilitate requirements gathering, monitor and ensure timely, high-quality deliverables.

• Handle numerous post Go-Live activities including amendments, system upgrades, and new/updated requirements.

• Single point of contact for Pharma client, addressing project needs and mitigating risks. Work with all onshore and offshore therapeutic areas and shared service roles to promote consistent operations, efficient use of resources and adherence of best practices and SOPs.

• Participate in special projects, continuous learning opportunities and provide mentoring/guidance to new team members as needed.

Data Services Design Manager

Almac Group
03.2019 - 10.2020

• Wrote and reviewed, provided instructional feedback on data transfer user requirement specification documents.

• Managed deliverables and communicated with client teams regarding timelines and deliverable status to ensure all milestones were met on time.

• Ensured that the functional requirements met the user's needs and were consistent with the objectives and scope of the project.

• Interacted with internal and external contacts to obtain, clarify, and verify the business needs that would be addressed in the proposed solution.

Project Manager

C3i Solutions
04.2018 - 03.2019

• Managed project scope and change requests and identified and coordinated joint milestones and deliverables.
• Provided business consultation to Merck cross functional team members and external vendors on all project related issues and decisions.

• Managed ongoing work against project plans, calculated and reported on key project metrics.

Education

Bachelor of Science in Digital Forensics -

Bloomsburg University of Pennsylvania
Bloomsburg, PA
05.2017

Skills

  • Clinical Data Management
  • Timeline and Risk Management
  • Electronic Data Capture (EDC)
  • Interactive Response Technology (IRT)
  • IVRS/InForm Data Transfer Specifications
  • Data Analysis and Migration
  • Verbal and Written Communication
  • Microsoft Office Suite and Microsoft Project
  • Conflict Resolution
  • Project Management
  • Strategic Planning
  • Client Relations

Presentations

Society of Clinical Data Management (SCDM) Conference, San Diego, CA, 10/01/23, 

Risk-Based Quality Management and Quality by Design in Clinical Trial Data Management: The Art of Building a Quality Database

Timeline

Clinical Data Management Project Manager

Accenture
10.2020 - Current

Data Services Design Manager

Almac Group
03.2019 - 10.2020

Project Manager

C3i Solutions
04.2018 - 03.2019

Bachelor of Science in Digital Forensics -

Bloomsburg University of Pennsylvania
ASHLEY SACCHETTI