Digital Implementation Manager II

Employment Type: Full time Work Schedule: Standard (Mon-Fri) Environmental Conditions: Office

Position Overview

When you join Thermo Fisher Scientific, you will do meaningful work that makes a positive impact on a global scale. Join 130,000 colleagues who bring our mission to life every single day to enable our customers to make the world healthier, cleaner, and safer!

PPD®, our Clinical Research portfolio, is a leading global contract research organization (CRO). We provide comprehensive, integrated drug development, laboratory, and lifecycle management services. Our customers include pharmaceutical, biotechnology, medical devices, academic and government organizations.

Our PPD group is opening a Digital Implementation Manager II position, which is an important member of the PPD Patient First Digital Solutions (PFDS) department. As a knowledgeable clinical professional, you will lead the implementation process of digital solutions for clinical trials, maintaining high standards of operational excellence, consistency, quality, and innovation. By applying various digital methodologies, you will play a crucial role in delivering exceptional solutions that directly improve health outcomes for individuals and communities.

Responsibilities

• Function as a subject matter expert for e-clinical digital solutions and services, both internally and externally, and lead the technical and operational aspects of the digital project.
• Collaborate with major functional area leads to identify and evaluate fundamental issues on the project, interpreting complex data, and make sound business decisions to ensure the successful implementation of digital solutions.
• Be accountable for ensuring that all project deliverables meet customer/contract expectations, providing accurate hour forecasts, reviewing pass-through costs, and ensuring timely invoices.
• Coordinate activities of all functional departments and vendors involved in the project, ensuring exceptional collaboration and communication.
• Function as the principal contact for the Sponsor, facilitating the flow of information and providing timely project updates and fiscal information.
• Work closely with finance and legal departments to manage all financial and contractual aspects of the study, including subcontracting with third-party service providers.
• Establish appropriate controls to ensure that project resources and expenses align with budgets.
• Provide training and guidance to team members as needed.

Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
• Proven experience with successfully implementing electronic Clinical Outcome Assessments (eCOA) and other clinical trial technology solutions, equivalent to 5+ years.
• In some cases, an equivalency, consisting of appropriate education, training, and/or related experience will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, and Abilities

• Working knowledge of eCOA's including the development, validation, translation, and migration (paper to electronic) process.
• Ability to scope eCOA implementation projects and create project plans and software requirements.
• Exceptional experience with system testing and writing test documentation, including script writing.
• Strong understanding of testing processes and SDLC.
• Previous system testing experience with digital technology, specifically eCOA.
• Ability to collaborate effectively with IT Developers on system enhancements and new functionalities.
• Confident self-starter with excellent problem-solving skills.

Company Information

Thermo Fisher Scientific is dedicated to enabling our customers to make the world healthier, cleaner, and safer. Our PPD portfolio is a leading global contract research organization (CRO) providing comprehensive, integrated drug development, laboratory, and lifecycle management services.