Sr Project Manager - NIS Experience - FSP

Position Overview

• Location Type: Hybrid
• Job Type: Full time
• Salary: Not provided
• Brief Description: The Study Manager has global responsibility for one or more studies of moderate complexity, generally with responsibility for all study management aspects of assigned studies. They provide quality oversight to the Contract Research Organization (CRO) and of the CRO deliverables related to study execution. This role involves leading the execution of clinical trials from study start-up through database close and inspection readiness, ensuring timely delivery of quality study data.

Requirements

• Not provided

Responsibilities

• Accountable for the development of realistic detailed study startup and monitoring plans as well as study delivery.
• Accountable for conducting country level feasibility in collaboration with Global Clinical Trial Execution and CROs.
• Reviewing Pre-trial Assessment outputs.
• Approving sites and assessing site activation plans.
• Leads study risk planning process in context of site and subject.
• Coordinate study/protocol training & investigator meetings.
• Develops and provides key inputs to Clinical Trial Budget.
• Leads inspection readiness activities related to study management and site readiness.
• May provide input to and support compilation of sections to Clinical Study Reports.
• Works with functional lines and directly with CRO line functions to resolve or triage site level issues.
• Drives decision making and works closely with the Clinical Project Manager to provide input to operational strategy.
• For studies where more than one Study Manager is assigned, may be required to act as ‘lead’ study manager, and will coordinate activities of the other Study Managers assigned.

Company Information

• Company: Thermo Fisher Scientific
• Mission: Enabling our customers to make the world healthier, cleaner and safer.
• Work Environment: Office and potentially hybrid.
• Clinical Trial Services: Provides clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through its PPD clinical research portfolio. Includes laboratory, digital and decentralized clinical trial services.

Additional Information

• This role will be embedded within a client dedicated team.
• The Study Manager will work alongside the client’s own experienced personnel, as well as PPD colleagues to deliver innovative clinical support.