Start Up Lead

📋 Description

• • As a Site Start Up Lead at Precision for Medicine, you will be at the forefront of enabling groundbreaking clinical research, specifically focusing on rare diseases and oncology, while also contributing to other therapeutic areas. This pivotal role is responsible for the end-to-end execution of the site start-up strategy and planning, ensuring that clinical trial sites are activated efficiently and effectively to support the advancement of precision medicine.
• • You will serve as a subject matter expert, guiding and supporting in-country team members, including Site Start Up Specialists (SUSs), Clinical Research Associates (CRAs), and Clinical Study Support Staff (CSSs), in navigating the complexities of global site activation. Your expertise will be crucial in troubleshooting challenges and ensuring adherence to best practices.
• • A key responsibility involves developing and implementing a comprehensive activation readiness strategy for each site. This includes meticulous planning and coordination of critical path activities such as core and site document collection and approval, informed consent form (ICF) customization and approval, Institutional Review Board (IRB)/Ethics Committee (EC) and Competent Authority (CA)/Ministry of Health (MoH) submissions, and the timely delivery of quality Investigational Medicinal Product (IMP) release packages.
• • You will be instrumental in fostering collaboration and communication across various internal and external stakeholders. This includes working closely with functional leaders, site start-up specialists, feasibility teams, clinical operations, project management, regulatory affairs, and site contracts management groups to ensure alignment on operational goals and timely delivery of all start-up milestones.
• • Proactively identify potential risks to the site activation timeline and develop and execute robust mitigation strategies to overcome these challenges. Your ability to anticipate and address issues will be critical to maintaining project momentum.
• • You will be responsible for overseeing the accuracy and real-time maintenance of tracking systems and data. This ensures that progress metrics can be accurately analyzed against targets and timelines at the study, country, and site levels, providing valuable insights for operational efficiency.
• • Coordinate the translation of essential documents required for regulatory submissions, ensuring compliance with local requirements in each country.
• • Act as a central point of contact for country-specific start-up activities, maintaining clear communication channels with all participating functions to ensure seamless progress.
• • You will be the go-to expert for collecting and maintaining critical path data points necessary for IMP release. This includes understanding and managing local IRB/EC timelines, other required reviews for site activation, contract and budget negotiation requirements, and other country-specific start-up prerequisites.
• • Where necessary, you will directly support country or site-level start-up activities, demonstrating a hands-on approach to problem-solving and execution.
• • Contribute to the development of country-specific Country Start-up summaries and process flows, clearly outlining timelines, potential risks, and key success factors.
• • Play a vital role in knowledge sharing by supporting the development and facilitation of training sessions for less experienced staff, expanding their understanding of country start-up processes and regulations.
• • You may be identified as the owner of country-specific tools and guidance documents, contributing to the growth of organizational knowledge and best practices.
• • Engage with clients during proposal activities, contributing to slide development and client presentations, showcasing the company's expertise in site start-up.
• • This role offers the opportunity to work remotely from Australia, Singapore, South Korea, or Taiwan, providing flexibility while contributing to a global mission.
• • You will be part of a growing organization dedicated to advancing therapies for challenging diseases, where your input and ideas will be valued and nurtured, leading to positive change and impact.