Start Up Lead APAC

📋 Description

• • As a Site Start Up Lead for the APAC region at Precision for Medicine, you will be instrumental in driving the successful initiation of clinical trial sites across Australia, Singapore, South Korea, and Taiwan. This pivotal role demands a deep understanding of global site start-up activities and the strategic execution required to bring groundbreaking therapies closer to patients.
• • You will be the central point of accountability for the entire site start-up process, from initial planning through to the delivery of essential components for clinical trial execution. This includes meticulously managing and coordinating a complex array of activities such as the collection and approval of core site documents, customization and approval of Investigator Site Files (ICFs), navigating the submission and approval processes with Institutional Review Boards (IRBs)/Ethics Committees (ECs) and Competent Authorities (CAs)/Ministries of Health (MoHs), and ensuring the timely delivery of Investigational Medicinal Product (IMP) release packages.
• • Your expertise will be sought after 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), who are involved in site start-up activities. You will also play a key role in training less experienced staff, sharing your knowledge and best practices to foster a high-performing team.
• • Furthermore, you may be tasked with owning country-specific tools and guidance documents, contributing to a robust knowledge-sharing infrastructure that enhances the efficiency and effectiveness of site start-up across the APAC region.
• • A core responsibility involves developing and implementing a comprehensive activation readiness strategy. This strategy will serve as the roadmap for overseeing site start-up delivery, ensuring all critical milestones are met and potential roadblocks are proactively addressed.
• • You will be responsible for coordinating, developing, and presenting critical path planning, encompassing the IRB/EC and CA/MoH submission strategy, ICF customization, risk mitigation plans, IMP release requirements, and contract execution. This requires a keen eye for detail and the ability to synthesize complex information into actionable plans.
• • Collaboration and communication are paramount. You will work closely with a diverse range of internal and external stakeholders to secure essential input for milestone planning and to ensure alignment of operational goals. This collaborative approach is crucial for the timely delivery of site start-up activities, enabling the on-time activation of trial sites.
• • You will actively participate in client meetings, setting clear expectations for delivery, communication protocols, risk mitigation strategies, status reporting, and key performance metrics related to site start-up. Building and maintaining strong client relationships through transparent and effective communication will be a key aspect of your role.
• • Partnering closely with Functional Leaders and Site Start-up Specialists, you will proactively identify any potential risks that could impede delivery. Your role will involve developing and executing robust mitigation strategies to eliminate these risks and ensure timelines are met.
• • You will provide essential oversight to ensure the accuracy and completeness of agreed-upon tracking systems. Maintaining these systems in real-time is critical for analyzing progress metrics against targets and timelines at the study, country, and site levels, providing valuable insights for continuous improvement.
• • A key logistical task will be coordinating the translation of documents required for regulatory submissions, ensuring compliance with local requirements.
• • You will maintain open and consistent communication with other key functions involved in country start-up, including Feasibility, Clinical Operations, Project Management, Regulatory Affairs, and the Site Contracts Management group, providing project-specific status updates and ensuring alignment on deliverables.
• • You will serve as the Subject Matter Expert for the collection and maintenance of critical site-level data points essential 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 start-up prerequisites for your assigned countries.
• • Where necessary, you will directly support country or site-level start-up activities, demonstrating a hands-on approach to problem-solving and execution.
• • You will contribute to the development of country-specific Country Start-up summaries and process flows, clearly identifying timelines, potential risks, and critical success factors.
• • You will support the development and facilitation of training sessions designed to enhance the knowledge base of the Country Start-up team, acting as a go-to resource for queries and expert advice.
• • Mentoring junior staff on local study start-up regulations, submission processes, internal procedures, and Site Start-up Documentation (SSDL) will be an integral part of your role, fostering professional growth within the team.
• • You will also interact with clients during proposal development activities, contributing to slide creation and client presentations as needed, showcasing the company's capabilities and your expertise.
• • This role offers a unique opportunity to contribute to the advancement of rare disease and oncology research, working with a passionate team dedicated to making a significant impact in precision medicine.