Job Description
Job Title: Clinical Operations Leader - Early Development Oncology Job Location: Durham, United States of America Job Location Type: Home-based Job Contract Type: Full time Job Seniority Level: Job Overview Senior Clinical Leads are an integral part of clinical trial delivery, leading and working alongside clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Senior Clinical Lead is a member of the core project team responsible for clinical delivery of full service, large, multi-regional studies to meet contractual requirements and in accordance with (Standard Operating Procedures) SOPs, policies and practices. Senior Clinical Leads ensure clinical delivery to customers by leading clinical teams and partnering with Project Leaders and other functional teams to ensure projects meet delivery requirements at all times. Essential Functions Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans). • Accountable for meeting projects’ recruitment targets and ensuring appropriate recruitment strategies are in place. • Contribute to the development of the project risk mitigation plan. Manage clinical risks through the project lifecycle. • Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues. • Manage clinical aspects of Project Finances including Estimate at Completion (EAC). Understand the scope of clinical delivery and create plans to deliver. Monitor and manage changes against baseline Estimate at Completion (EAC) and identify additional service opportunities or out of scope work. • Work as the primary Clinical Lead alongside other Clinical Leads to deliver large,
