Senior Clinical Project Manager

Position Overview

• Location Type: Remote
• Employment Type: Full time
• Salary: Not specified

The Sr. Project Manager serves as a project lead to ensure the efficient implementation of study protocols. The Sr. PM works closely with all Clinical Operations and cross-functional team members and communicates directly with study sponsors and vendors. The Sr. PM serves as an important resource for less experienced team members and assists with team training, process improvements, and other initiatives.

Requirements

• BS/BA from an undergraduate program (life sciences or related field)

Responsibilities

• Manages clinical research studies to ensure studies are conducted in accordance with approved scope of work/budget, ICH GCP guidelines, and FDA regulations and within established timelines.
• Serves as project lead and primary contact for sponsors.
• Oversees all clinical study functions, which may include investigational supply, IWRS/IXRS, data management, biostatistics, pharmacovigilance, and central laboratory.
• Generates and presents frequent study status updates and reports to sponsors.
• Supervises and provides support to the Clinical Operations team, including Clinical Assistants, In-house Clinical Research Associates, and Clinical Research Associates.
• Assists with training of Associate Project Managers (APMs) and provides ongoing support and high-level guidance to PMs.
• Creates and reviews clinical study documents, including protocols, ICF templates, site study budgets, site log/form templates, study manuals and plans, etc.
• Drives and facilitates teamwork and communication to ensure timely attainment of trial milestones and delivery of quality work product.
• Ensures accuracy of reports and material work product.
• Provides monthly billing and revenue information to finance team.
• Presents at project meetings such as investigator meetings and new client meetings.
• Updates management accurately and regularly through frequent communication.
• Identifies issues and develops problem-solving strategies to ensure study timelines are met.
• Manages subject accrual, retention, and compliance.
• Coordinates/assists with TMF management and TMF reviews as needed.
• Prepares for and participates in third-party audits and FDA inspections.
• Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company SOPs.
• Participates in internal, client/sponsor, scientific, and other meetings as required.
• Travel for participation in client meetings or for other in-person activities as required (< 20%), including the ability to travel internationally.
• Performs additional duties as assigned.

Company Information

• The company emphasizes collaboration, innovation, and shared values: be courageous, be accountable, be honest, be inclusive and elevate others.