Clinical Operations Lead

Overview

Clinical Operations Lead, RWE

The COL leads the execution of the Site & Patient Services (SPS) components of Real World Late Phase Research (RLWPR) studies by applying clinical research expertise, exceptional decision-making skills and innovative approaches to problem solving. Proactively set project goals and tangible expectations for SPS project team members

Essential Functions

• Oversee the delivery of Site Management project tasks, providing advice and guidance to achieve high performance and quality project deliverables.
• Ensure overall project efficiency and adherence to project timelines and financial goals; report metrics and out of scope activities.
• Develop, implement and maintain the Site Recruitment, SPS Operations and SPS Risk Management Plan within the agreed project strategy.
• Collaborate with other functional groups within the company such as data management, quality assurance and biostatistics where necessary to support milestone achievement and to manage study issues and obstacles.
• Manage and follow study activities through ongoing tracking and review of study progress. Provide input and report progress to appropriate SPS management and project management leaders.
• Act as the first line of escalation for site management questions and issues on assigned projects.
• Lead preparation for in-house audits and in creation of Corrective Action Plans (CAPAs).
• Develop and deliver presentations / training to clients, colleagues and professional bodies, as required.

Requirements

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