Start Up Lead

📋 Description

• • As a Site Start Up Lead at Precision for Medicine, you will be instrumental in driving the successful initiation of clinical trial sites across various global locations, including Australia, Singapore, South Korea, and Taiwan. Your expertise will be crucial in ensuring that our groundbreaking research, particularly in rare diseases and oncology, can commence efficiently and effectively.
• • You will be the central point of contact and subject matter expert for all site start-up activities, guiding the process from initial documentation to the readiness for investigational medicinal product (IMP) release. This involves a deep understanding of regulatory requirements, ethical considerations, and operational logistics.
• • Your primary responsibility will be to develop and execute a comprehensive site start-up strategy, meticulously planning and coordinating critical path activities. This includes the collection and approval of core and site-specific documents, customization and approval of informed consent forms (ICFs), and managing submissions to Institutional Review Boards (IRBs)/Ethics Committees (ECs) and Competent Authorities (CAs)/Ministries of Health (MoHs).
• • You will proactively collaborate with a diverse range of internal and external stakeholders, including clinical operations teams, project managers, regulatory affairs, and site contract management groups. This cross-functional collaboration is essential for aligning operational goals, securing necessary inputs, and ensuring the timely delivery of all start-up milestones.
• • A key aspect of your role will be to establish and manage client expectations regarding delivery timelines, communication protocols, risk mitigation strategies, and status reporting. You will participate in client meetings, presenting project status, identifying potential risks, and proposing effective solutions.
• • You will partner closely with Functional Leaders and Site Start-up Specialists, providing guidance and oversight to proactively identify any potential risks to the start-up process. Your role involves developing and executing robust mitigation plans to ensure that timelines are met and challenges are overcome.
• • Maintaining accurate and up-to-date tracking systems and data is paramount. You will ensure that all site-level critical path data points, such as local IRB/EC timelines, contract and budget negotiation requirements, and other essential start-up prerequisites, are meticulously recorded and maintained in real-time. This data will be used to analyze progress metrics against targets at study, country, and site levels.
• • You will be responsible for coordinating the translation of essential documents required for regulatory submissions, ensuring accuracy and compliance with local requirements.
• • Acting as a Subject Matter Expert (SME), you will provide support and guidance to less experienced team members, including Site Start-up Specialists (SUSs), Clinical Research Associates (CRAs), and Clinical Study Support Staff (CSSs), on best practices and country-specific nuances in site start-up activities.
• • You may also be tasked with developing and facilitating training sessions to enhance the knowledge base of the team regarding country-specific start-up regulations, submission processes, internal procedures, and the Site Start-up Lifecycle (SSDL).
• • In addition to providing oversight, you may be required to directly support country or site-level start-up activities when necessary, demonstrating a hands-on approach to problem-solving.
• • You will contribute to the development of country-specific start-up summaries and process flows, identifying key timelines, potential risks, and critical success factors.
• • Your involvement may extend to proposal activities, including the development of presentation materials and client presentations, showcasing your expertise and contributing to business development efforts.
• • This role offers a unique opportunity to contribute to a leading Clinical Research Organization (CRO) at the forefront of precision medicine, working with clients dedicated to developing groundbreaking therapies, particularly in oncology and rare diseases.
• • You will be part of a growing organization where your contributions are valued, and your ideas are nurtured, leading to positive change and impacting the future of medical research.