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 within the rare diseases and oncology therapeutic areas, while also contributing to other vital areas of medicine.
• • You will serve as a pivotal expert in global site start-up activities, taking full accountability for the strategic planning and flawless execution of this critical phase in clinical trials.
• • Your role will involve the meticulous management and coordination of a wide array of essential activities, including the collection and approval of core and site-specific documents, the customization and approval of Informed Consent Forms (ICFs), and the successful submission and delivery of Investigational Medicinal Product (IMP) release packages to Institutional Review Boards (IRBs)/Ethics Committees (ECs) and Competent Authorities (CAs)/Ministries of Health (MoHs).
• • You will be the go-to Subject Matter Expert (SME) for any queries raised by in-country team members, such as Site Start-Up Specialists (SUSs), Clinical Research Associates (CRAs), or Clinical Study Support Staff (CSSs), ensuring consistent and accurate application of start-up procedures.
• • A key aspect of your role will be to act as a trainer for less-experienced staff, sharing your deep knowledge and best practices in site start-up activities, thereby fostering a culture of continuous learning and development within the team.
• • You may also be designated as the owner of country-specific tools and guidance documents, playing a crucial role in knowledge sharing and enhancing the efficiency of site start-up processes across different regions.
• • You will develop and implement a comprehensive activation readiness strategy, providing robust oversight to ensure the timely and successful delivery of site start-up activities.
• • This includes the critical path planning for essential milestones such as IRB/EC and CA/MoH submissions, ICF customization, risk mitigation strategies, IMP release requirements, and contract execution.
• • You will foster strong collaborative relationships with diverse stakeholders, actively seeking their input for milestone planning and ensuring alignment of operational goals to guarantee the on-time activation of study sites.
• • A significant part of your responsibility will involve participating in client meetings, where you will establish client expectations for delivery, communication protocols, risk mitigation strategies, status reporting, and key metrics related to site start-up performance.
• • You will partner closely with Functional Leaders and Site Start-Up Specialists to proactively identify potential risks to project delivery and to develop and implement effective mitigation plans to keep timelines on track.
• • You will provide diligent oversight to ensure that agreed-upon tracking systems and data are maintained in real-time, enabling accurate analysis of progress metrics against targets and timelines at study, country, and site levels.
• • You will be responsible for coordinating the translation of documents essential for regulatory submissions, ensuring compliance with local requirements.
• • Maintaining open and effective communication with other key functions involved in country start-up, such as Feasibility, Clinical Operations, Project Management, Regulatory Affairs, and the Site Contracts Management group, will be crucial for project-specific status updates and deliverable management.
• • You will act as an SME for the collection and maintenance of critical path data points required for IMP release, including local IRB/EC timelines, other necessary 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 flexibility and a hands-on approach.
• • 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.
• • You will support the development and facilitation of training sessions aimed at expanding the team's knowledge of Country Start-up procedures and serve as the primary point of contact for related queries.
• • You will mentor junior staff on local study start-up regulations, submission processes, internal procedures, and Site Start-Up Logistics (SSDL).
• • You will engage with clients during proposal activities, contributing to slide development and client presentations as needed, showcasing your expertise and the company's capabilities.
• • This role offers a unique opportunity to contribute to a growing organization dedicated to advancing life-saving therapies, particularly in oncology and rare diseases, and to have your ideas valued and nurtured in a dynamic environment.