Purpose, Objectives and Scope of Position As a member of the PDG Country Study Start-Up Team, your primary focus is to drive and facilitate efficient study start-up processes to contribute to the delivery of clinical trials to patients. You will enable innovative clinical trial delivery, address study start up needs across various therapeutic areas, and ensure seamless trial execution for patients, investigators, and clinical site staff. Collaboration with local internal and external country teams, global study teams, and CROs is essential to this role. Key Responsibilities This role focuses on the efficient and compliant initiation of Roche-sponsored clinical trials by developing and implementing effective start-up strategies, overseeing start-up operations, and driving process improvements at the country and site level while maintaining regulatory compliance. Key responsibilities include: Leading the country strategy for study start-up, driving efficiency, innovation, and collaboration with external stakeholders. Overseeing start-up operations and ensuring timely and efficient site activation and regulatory compliance. Ensuring alignment with global strategies and timelines. Managing amendments throughout the study lifecycle. Engaging with government and institutional bodies to align on clinical trial policies and practices (e.g., with Ethics Boards, Health Authorities). You will lead in a cross functional environment in multiple of the following areas below: Lead teams in the creation of the study start-up strategy and execution of the study start-up process, encompassing strategy development, proactive risk mitigation, regulatory compliance, stakeholder liaison, tracking, knowledge management, and collaborative planning with CRO partners. Architect and strategically oversee ICF management, including preparation, submission, archiving to ensure compliance, alignment with the corporate requirements and best practices Clinical Trial Submissions
Clinical Study Start Up Specialist employer: Randstad UK
As an Operations Administrator with us, you'll enjoy a flexible home-working environment while being part of a dynamic team that plays a vital role in our business success. We prioritise employee growth and development, offering opportunities for recent graduates to kickstart their careers in a supportive culture that values collaboration and communication. With regular travel to various regional offices, you will experience diverse working environments and build connections across the company.
