Study Start-up II - IVD

Drive global clinical trials forward as a Site Activation Specialist-where precision meets collaboration. R&D Partners is seeking a Site Activation Specialist with 3-5 years of experience to support site start-up activities for assigned studies within the Site Alliance and Site Activation Sub-Chapter under Clinical Operations. This role requires strong stakeholder management and collaboration with Contracting, Legal, Privacy, Study Teams, CROs, and Sites. Please note that to be considered for this role you must have the right to work in this location. Responsibilities:Oversee site activation deliverables across all regions for assigned projects. Support pre-study site identification and selection through feasibility data collection and analysis. Maintain regular communication with investigational sites and CROs to ensure timely completion of site activation activities and resolve/escalate issues as needed. Collect, review, and manage study-specific site regulatory and essential documents per SOPs, guidelines, and timelines. Coordinate IRB/Ethics Committee and other regulatory submissions in collaboration with sites and study teams. Ensure informed consent forms meet regulatory and company requirements. Facilitate translation of essential documents for regulatory submissions. Manage clinical trial insurance processes and support throughout the study. Assist with contract and budget negotiations alongside Contracting and Study Teams. Ensure timely completion of purchase orders and Fair Market Value assessments. Support study instrument placements and obtain import/export licensure. Implement and support the use of eTools at the site level. Maintain country, local, state, and site-level regulatory intelligence for future use. Collaborate with Study Teams to complete start-up tasks and escalate issues as needed. Support internal audits, external inspections, and contribute to CAPAs as required. Key Skills and Requirements:Associate or Bachelor's degree in chemistry, biology, life sciences, or related field (or equivalent experience). Proven experience in study start-up is required. Experience with CRO management is a plus. Knowledge of clinical trial planning, including IRB/Ethics Committee and Competent Authority submissions and contracts. Familiarity with clinical trial methodologies, medical terminology, and ICH-GCP guidelines. Fluency in English and the language of the appointed location. Working knowledge of global/local regulatory requirements, IVDR, and other applicable regulations is a plus. Strong attention to detail and commitment to quality standards. Ability to organize tasks, prioritize, and multi-task effectively. Flexibility to support multinational team members and adjust working hours as needed. Effective collaboration with cross-functional teams. For more information, please contact Elliot Croft If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page. R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy. By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.r-dpartners.com/privacy-policy/