Start Up Lead APAC

📋 Description

• • As a pivotal member of our expanding global team, you will serve as the Site Start-Up Lead for the Asia-Pacific (APAC) region, driving the successful initiation of clinical trial sites. This remote role offers the flexibility to be based in Australia, Singapore, South Korea, or Taiwan, allowing you to contribute to groundbreaking research from a location that suits you.
• • Precision Medicine Group is at the forefront of advancing precision medicine, a field dedicated to tailoring medical treatment to the individual characteristics of each patient. We are a leading Clinical Research Organization (CRO) with a unique, integrated approach that combines innovative clinical trial designs, unparalleled operational and medical expertise, sophisticated biomarker and data analytics solutions, and a profound commitment to rare diseases and oncology, alongside other critical therapeutic areas.
• • In this critical role, you will be the expert responsible for the end-to-end site start-up process. This encompasses developing and executing a comprehensive site activation readiness strategy, ensuring meticulous oversight of all start-up deliverables. Your strategic planning will be essential, covering the critical path for activities such as Institutional Review Board (IRB)/Ethics Committee (EC) and Competent Authority (CA)/Ministry of Health (MoH) submissions, Investigational Medicinal Product (IMP) release requirements, and contract execution.
• • You will be instrumental in coordinating and developing these critical path plans, presenting them clearly to stakeholders, and proactively identifying and mitigating risks that could impact timelines. Your ability to collaborate effectively with a diverse range of internal and external stakeholders will be key to securing input, aligning operational goals, and ensuring the timely activation of sites, which is paramount for the successful commencement of clinical trials.
• • A significant aspect of your role will involve partnering closely with Functional Leaders and Site Start-up Specialists. You will proactively identify potential risks to delivery and work collaboratively to develop and implement robust mitigation strategies to keep projects on track. Your leadership will ensure that agreed-upon tracking systems and tools are maintained in real-time, providing accurate data for analysis of progress metrics against targets at study, country, and site levels.
• • You will act as a Subject Matter Expert (SME), providing guidance and support to other in-country team members, including Site Start-up Specialists (SUSs), Clinical Research Associates (CRAs), and Clinical Study Support Staff (CSSs), on all aspects of site start-up activities. Furthermore, you will be responsible for coordinating the translation of documents essential for regulatory submissions, ensuring compliance and efficiency.
• • Maintaining clear and consistent communication with other key functions involved in country start-up is vital. This includes close collaboration with Feasibility teams, Clinical Operations, Project Management, Regulatory Affairs, and the Site Contracts Management group, ensuring seamless information flow regarding project-specific status and deliverables.
• • You will be the go-to expert for the collection and maintenance of critical site-level data points required for IMP release. This includes understanding and tracking local IRB/EC timelines, other necessary reviews for site activation, contract and budget negotiation requirements, and any other specific start-up needs for your assigned countries within the APAC region.
• • In situations where direct support is needed, you may be called upon to assist directly with country or site-level start-up activities, demonstrating a hands-on approach to problem-solving.
• • You will contribute to the development of country-specific Country Start-up summaries and process flows, clearly identifying timelines, potential risks, and key success factors. This documentation will be crucial for knowledge sharing and standardization across the region.
• • A key part of your role will involve supporting the development and facilitation of training sessions designed to enhance the knowledge and skills of less experienced staff in Country Start-up activities. You will serve as a primary point of contact for queries, sharing your expertise and mentoring staff on local study start-up regulations, submission processes, internal procedures, and the Site Start-up Lifecycle (SSDL).
• • You will also have the opportunity to engage with clients during proposal activities, contributing to slide development and client presentations, showcasing your expertise and the capabilities of Precision Medicine Group.
• • This role is an exceptional opportunity to make a significant impact within a growing organization dedicated to advancing cancer therapies and other critical treatments. You will be empowered to provide input, have your ideas valued and nurtured, and contribute to positive change within the company, all while working remotely in a dynamic and expanding region.