Associate 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 Associate Clinical Lead is a member of the core project team, responsible for clinical delivery of clinical studies to meet contractual requirements in accordance with Standard Operating Procedures (SOPs), policies and practices. Associate Clinical Leads partner with Project Leaders and other functional teams to secure delivery requirements are met at all times.
Tasks & Responsibilities:
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 and manage clinical risks throughout 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 Estimate at Completion (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 trainings
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 work as the sole Clinical Lead on projects with 1-2 service lines and single/few countries or alongside more senior Clinical Leads to deliver large, global trials
May attend site visits as applicable in support of project delivery
Essentials Requirements:
Bachelor's degree in a health care or other scientific discipline with 3 years clinical research/monitoring experience; or equivalent combination of education, training and experience
Requires broad protocol knowledge and therapeutic knowledge
Requires basic understanding of project finances
Ability to identify and organize clinical resources needed to accomplish tasks, set objectives and provide clear direction to others; experience planning activities in advance and taking account of possible changing circumstances
Requires good knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
