Job Title: Clinical Study Manager
Location: Durham, North Carolina
Type: 12-month Contract
Work Model: Onsite
Hours: 40.0

Overview

The Clinical Study Manager provides onsite operational oversight for assigned clinical studies from start-up through close-out, ensuring delivery aligns with ICH/GCP, regulatory requirements, and internal SOPs. This role partners with cross-functional teams, CROs/vendors, and study sites to drive timelines, manage risks/issues, and maintain inspection-ready documentation using tools such as CTMS/eTMF/EDC.

Responsibilities
• Provide day-to-day study management support and oversight for assigned clinical study activities from start-up through close-out.
• Coordinate with internal project team members, CROs, vendors, investigators, and study coordinators to support milestone achievement and timely delivery of study activities.
• Monitor adherence to essential document collection processes, site activation re...