Clinical Lead

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 Standard Operating Procedures (SOPs), policies and practices. 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 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). 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. Resourcing and Talent Planning of the clinical team. 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. Qualifications Bachelor's Degree in health care or other scientific discipline required Requires 5 years clinical research/monitoring experience or equivalent combination of education, training and experience. Requires basic knowledge of Project management practices and terminology. Requires good knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Requires broad protocol knowledge and therapeutic knowledge. Requires good understanding of Clinical Research industry and the relevant environments in which it operates. Requires understanding of project finances. Skills Strong written and verbal communication skills including good command of English language. Problem solving skills. Planning, time management and prioritization skills. Ability to handle conflicting priorities. Attention to detail and accuracy in work. Good influencing and negotiation skills. Effective mentoring and training skills. Good software and computer skills, including Microsoft Office applications. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Ability to work across geographies displaying high awareness and understanding of cultural differences. Salary The potential base pay range for this role, when annualized, is $93,100.00 - $232,800.00. Job Data by YubHub .