Please note that, due to sponsor requirements, only applicants in the specified locations with previous Clinical Lead (Clinical Trial Management) experience within a CRO environment will be considered for the role. Job Overview Clinical Leads are an integral part of clinical trial delivery, working alongside clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Clinical Lead is a member of the core project team responsible for the clinical delivery of clinical studies to meet contractual requirements in accordance with SOPs, policies, and practices. Clinical Leads ensure clinical delivery to customers, lead clinical teams and partner with Project Leaders and other functional teams ensuring projects meet delivery requirements at all times. Essential Functions Ensure clinical delivery of assigned projects in compliance with regulatory requirements (ICH‑GCP, protocol), customer requirements (contract), and internal requirements (policies, SOPs, project plans). Accountable for meeting projects’ recruitment targets and ensuring appropriate recruitment strategies are in place. Contribute to development of the project risk mitigation plan and manage clinical risks through the project’s 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 EAC and identify additional service opportunities or out‑of‑scope work. Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management. Collaborate with the clinical team to support milestone achievements. Report to internal and external stakeholders as per project scope requirements. Resourcing and Talent Planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of high‑quality operational plans and guidance and project‑related training. Conduct regular team meetings and communicate appropriately to achieve objectives. Support professional development by providing feedback to clinical team line managers on performance relative to project tasks. May contribute to the development of the clinical delivery strategy for proposals. Participate in bid defense preparations and meetings. Develop and present a Clinical Operation plan in partnership with Business Development and Project Leadership. May mentor and coach new peers as they assimilate into this role. May work as a primary Clinical Lead alongside other Clinical Leads to deliver large, global trials. May attend site visits as applicable in support of project delivery. Qualifications Bachelor’s Degree in health care or another scientific discipline. Five years of clinical research/monitoring experience or an equivalent combination of education, training, and experience. Basic knowledge of project management practices and terminology. Good knowledge of applicable clinical research regulatory requirements, i.e., GCP and ICH guidelines. Broad protocol knowledge and therapeutic knowledge. Good understanding of the clinical research industry (drug/device/technology/etc.) and the relevant environments in which it operates. Understanding of project finances. Knowledge of clinical trial conduct and skill in applying applicable clinical research regulatory requirements, i.e., ICH and GCP and relevant local laws, regulations and guidelines, toward clinical trial conduct. #J-18808-Ljbffr