Job Description

Why Join Us?

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Position Overview

Manages and has direct oversight for a portfolio of projects for a specific client and is accountable for overall project/portfolio performance. Proactively identifies resources, budgets projects, prioritises client's portfolio in line with site-wide portfolio of projects and is the primary operational interface between PPD and the client. Negotiates and makes real-time decisions with the client. Provides internal consulting on project management issues and sees opportunities for process and efficiency improvement. Acts as chief liaison to the operational personnel of major clients and is responsible for large study programs.

A Day in the Life

• Provides oversight and coordination of client portfolio.
• Provides oversight to internal departments and external clients to ensure project requirements are understood, agreed, and followed at all times, requiring negotiation and real-time decision-making with the client.
• Facilitates the flow of technical and clinical laboratory information to all collaborators (investigational sites, sponsors, and non-technical personnel).
• Consults and utilizes, where appropriate, the scientific input of laboratory management and technical staff to assist the client with project management.
• Prepares project specifications documents and ensures preparation aligns with budgets and contracts.
• Maintains an updated project master file with version controls for specifications, budgets, and contracts.
• Ensures sponsors have authorized and signed off on the most recent versions of all documents and that a contract exists prior to delivering any services.
• Assures compliance with FDA, ICH, and Good Clinical Practice guidelines, PPD SOPs, personnel policies and procedures, PPD Exposure Control Plan, and applicable regulations regarding the transport of biological specimens.
• During initial review of project documentation, consults with internal groups and support staff regarding procedural and budgetary items and the necessity for change due to any subsequent project documentation amendments.
• Obtains commitment from other functions to close gaps and address issues timely and effectively.
• Serves as chief liaison between the sponsor and all PPD internal departments performing required tasks during all project phases.
• Controls, manages, and follows day-to-day activities during the course of the project to resolve any issues and answer queries.
• Actively coordinates with IT and data management development groups in the design, validation, and implementation of new software and functionalities pertinent to project management activities.
• Consults with BD and finance staff during initial project documentation review on standard practices.

Employment Type

Full-time

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Location Type

[Information not provided]

Salary

[Information not provided]