Apply on Employer Site

Syneos Health · 1 month ago

Clinical Operations Lead / Project Manager - 6 months contract

United States

Full-time, Contract

Remote

Mid Level

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. The Clinical Operations Lead / Project Manager will support overall project management of clinical studies, helping control the scope, schedule, and cost of assigned projects, while liaising with customers, vendors, and investigative sites.

BiotechnologyHealth CarePharmaceuticalTherapeutics

H1B Sponsor Likely

Responsibilities

Creates and maintains the Trial Master File Management (TMF) Plan. Routinely reviews the TMF to ensure quality, completeness and inspection readiness

Coordinates and monitors the activities associated with study deliverables across all applicable internal functional departments and vendors

Assists with activities associated with interim analyses, database snapshots and locks, final CSR and study closure

Assists with identification of and contracting with approved vendors, as necessary

Provides vendor management, inclusive of ensuring key deliverables are met, potential scope creep is identified and change orders are developed, as necessary

Assists with development and implementation of change orders

Assists with resource management and team member transition by collaborating with appropriate Resource Managers and ensuring detailed Transition Plans are developed and implemented efficiently

Develops contingency planning and risk mitigation strategies to ensure meeting or exceeding study milestones

Creation and maintenance of metric reports, inclusive of data collection from multiple sources, for delivery to client or senior management

Assists with overall financial performance of the study by interacting with internal functional departments or vendors to obtain required metrics for financial reporting

Attends financial review meetings to assist with reconciliation and identification of budget overrun

Reviews and approves invoices from sites or vendors and to the client

Participates in representing the company to the client, ensuring satisfaction levels are met and statuses of deliverables are communicated effectively

May participate in Customer proposal development

In collaboration with the Project Team, will plan, coordinate and present at internal and external meetings

Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training

Develops knowledge of current therapeutic environment

Qualification

Clinical Study ManagementVendor ManagementProject ManagementFinancial ReportingRisk MitigationTeam TrainingCommunication SkillsCollaboration

Required

Supports overall project management of clinical studies by helping control the scope, schedule and cost of assigned project(s)

Liaising with Customers, vendors and/or investigative sites to manage projects from proposal development to final deliverables to the customer

Creates and maintains the Trial Master File Management (TMF) Plan

Routinely reviews the TMF to ensure quality, completeness and inspection readiness