Summary
Overview
Work History
Education
Skills
Timeline
Generic

Isabelle Martella

Dublin,PA

Summary

As an accomplished Clinical Project Manager, I have diligently overseen and directed Interactive Response Technology (IRT) projects, ensuring seamless coordination and successful execution across multiple phases. My tenure at Almac Group empowered me to manage the entire project lifecycle, proficiently steering pre-and post-live IRT activities. This involved meticulous management of scope, budget, timelines, and quality standards while fostering robust client relationships. My expertise includes in-depth collaboration with diverse internal and external stakeholders to ensure regulatory compliance, timely deliverables, and efficient project execution, aligning seamlessly with Good Clinical and Manufacturing Practices (GCP, GMP), and industry-standard protocols. At Merck, my stint in Regulatory Affairs fortified my knowledge in quality review, FDA compliance, and meticulous documentation, critical facets synonymous with the job's demands. Furthermore, my experience extends to strategic leadership, problem- solving acumen, and adeptness in managing projects with tight deadlines and limited resources. These competencies, honed across diverse industries, align with the responsibilities outlined in driving IRT system development, coordinating global teams, and spearheading cross-functional projects. In my roles, I have showcased exceptional organizational skills, adeptness in handling multifaceted tasks, and a proven track record in effective communication at all levels, essential qualities requisite for excelling in any position.

Overview

8
8
years of professional experience

Work History

Clinical Project Manager

Almac Group
05.2022 - Current
  • Identifies and manages project tasks, dependencies, and critical path and documents this on project plan/schedule
  • Provide leadership on Interactive Response Technology (IRT) related projects through coordinating and facilitating internal and external project meetings and completing meeting minutes
  • Manage and oversee activities related to Interactive Response
  • Technology (IRT) projects during pre and post live phases with primary responsibilities for managing scope, budget, quality, timelines,project deliverables, and client relationship
  • Interact effectively with different functional areas within company as well as with external client, sponsor, and/or vendor personnel
  • Provides necessary documentation to appropriate departments and external stakeholders for compliance audits
  • Ensure study and amendments are in compliance with current FDA approved protocols
  • Understands system amendment scope and facilitates conversations about scope, timelines, cost and risk with client and internal team
  • Communicates and assesses budget implications with internal team members and client
  • Develops and drives project schedule to ensure timelines are met with input from project team
  • Oversees coordination and finalization of project documents regarding project status and reports results to stakeholders
  • Establishes and coordinates activities using company's established processes and procedures
  • Actively participates in identifying, mitigating, and managing risk and raises concerns to client and internal team
  • Ensure timely delivery and completion of project deliverables over life of project
  • Manages Change Control process and raises Change Control Forms (CCFs) and Change Requests (CRs)
  • Resolves conflicts and negotiates successful solutions with internal and external stakeholders
  • Communicates effectively with all levels of stakeholders including executives
  • Identifies potential risks and develops strategies for mitigating them
  • Successfully manages projects with tight deadlines and limited resources
  • Documents lessons learned to optimize future processes.
  • Managed cross-functional teams, resulting in seamless collaboration and increased productivity in clinical projects.

Regulatory Affairs Submissions Project Manager

Merck
05.2021 - 05.2022
  • Provided quality review and management of approved materials from Promotion Review Team upon their submission to the FDA
  • Supported Global Standards and Services, U.S Brand teams, Customer Solutions, and Public Affairs to assure promotional materials satisfy U.S
  • Promotional regulations, corporate standards, and policies and business objectives
  • Create or update supporting documentation to drive compliance with submission standards and metadata accuracy
  • Supported activities generated from the Global Human Health Quality
  • Management System initiative to ensure materials are of high quality and comply with standards, guidelines, and regulations
  • Supported tracking and reporting on status and deviations found during quality reviews to make processes more efficient
  • Performed routine consulting with promotion job owners on regulatory standards and process compliance.

Director of Client Engagement and Strategic

Highwater
05.2020 - 05.2021
  • Executed marketing campaigns and develop clients' goals with sales engagement team
  • Strategized with CEOs and directors at mid-market businesses to solve their marketing challenges
  • Utilized LinkedIn for campaign executions and provide analytical reports to team
  • Imported and exported leads through Customer Relationship Management (CRM)
  • Formulate content for LinkedIn on behalf of clients, as well as create phone and email scripts
  • Prepared marketing materials for qualified leads, such as whitepapers, surveys, and event invites
  • Provided daily statistics to team members
  • Worked on behalf of multiple clients by implementing predictive dialer system to make 100+ cold calls
  • Maintained strong and positive relationships with current and potential clients
  • Produced and updated data sheets daily for clients and team members
  • Used ZoomInfo depending on lead generation and lead qualification.

Sales Associate

Sherwin-Williams Paints
05.2016 - 11.2019
  • Helped to achieve monthly sales goals and consistently opened the most new accounts per month
  • Enticed customers with sales and promotions to boost sales
  • Provided accurate information about products, prices, and availability both in person and over phone
  • Maintained and built positive customer relationships by making daily calls, following-up, and providing helpful information on product selection, resulting in many repeat customers
  • Drove sales through customer relationship building and suggestive selling techniques
  • Demonstrated exceptional customer service skills, resolving customer complaints efficiently and courteously
  • Developed strong rapport with customers and created positive impression of business
  • Consistently increased levels of responsibility including training new employees, opening and closing store, and closing out registers
  • Encouraged customers to make additional purchases and suggested relevant items

Education

Bachelor of Arts - Criminal Justice and Psychology

Temple University
Philadelphia, PA
05.2019

Skills

  • Budget Management
  • Client Relationship Management
  • Compliance Audits
  • Conflict Resolution
  • Electronic Data Capture (EDC)
  • FDA Compliance
  • Interactive Response Technology (IRT)
  • Medidata RAVE
  • Project Management
  • Relationship Building
  • Risk Mitigation
  • Stakeholder Communication
  • Timely Deliverables
  • Veeva

Timeline

Clinical Project Manager

Almac Group
05.2022 - Current

Regulatory Affairs Submissions Project Manager

Merck
05.2021 - 05.2022

Director of Client Engagement and Strategic

Highwater
05.2020 - 05.2021

Sales Associate

Sherwin-Williams Paints
05.2016 - 11.2019

Bachelor of Arts - Criminal Justice and Psychology

Temple University
Isabelle Martella