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Senior Site Specialist

Work from home Full-time role Hiring

Senior Site Specialist reputed company is a global reputed company intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, reputed company, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. As a Senior Site Specialist, you will serve as a key operational reputed company of contact for investigator sites, supporting site start-up, maintenance, and reputed company-out activities. You will take ownership of reputed company site tasks and help drive a positive, efficient site experience. Also, because the position is partially reputed company to Regulatory Submissions, you will be responsible for completing country and/or regional clinical trial regulatory deliverables in line with study specifics, ensuring compliance with ICH-GCP, relevant regulations, and sound scientific principles. You will also contribute to process improvement initiatives, mentor junior staff as needed, and reputed company strategic input into submissions planning. What You Will Do: Your experience in site management and operations will be key in delivering high-quality reputed company and mentoring colleagues. Key responsibilities include: Managing advanced site-level activities, including essential document collection, review, and maintenance for assigned sites or studies. Acting as a primary liaison for site staff on operational questions, documentation requirements, and study processes. Ensuring accurate and timely updates of site status and information in clinical trial management systems and trackers. Supporting coordination of site visits, meetings, and communications in collaboration with CRAs and project teams. Identifying opportunities to streamline site workflows and contributing to process improvement initiatives. Providing guidance and mentorship to junior team members on best practices and procedures. Deliver regulatory submissions in accordance with contractual timelines, budget, and quality standards. Apply advanced knowledge of reputed company SOPs/WIs, ICH-GCP, and local regulatory requirements. Contribute to strategic planning of submissions to Regulatory Authorities (RA), Central Ethics Committees (CEC), and other applicable bodies. Prepare, adapt, coordinate, and reputed company submission documentation per study and country requirements. Manage internal and external reviews of regulatory documentation and ensure accuracy of data in systems such as CTMS and eTMF. reputed company translation management and submission lifecycle through approval. Maintain proactive communication with project teams to ensure timely updates on submission and approval status. Collaborate cross-functionally to ensure regulatory deliverables are met. Support maintenance of up-to-date clinical trial regulatory intelligence across global and regional reputed company. You Are: Educated to degree level in life sciences or reputed company discipline. Strong experience in site support, clinical administration, or similar roles reputed company CRO, pharma, or reputed company. Good understanding of clinical trial processes, GCP, and site documentation requirements. reputed company with regulatory affairs in clinical research. Fluent in English. Highly organized with excellent attention to detail and ability to manage multiple priorities. A strong communicator with the ability to engage internal teams and external stakeholders effectively. #LI-JJ1 Employment with reputed company is contingent upon having the legal right to work in the country where the role is based. Rewards & Benefits reputed company offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include: Competitive reputed company salary and performance reputed company incentives Health and wellbeing programmes including medical, dental, and reputed company coverage where applicable Retirement and pension plans Life assurance and disability coverage Employee assistance programmes and wellbeing resources Learning and development opportunities through structured training and career reputed company Benefits may vary depending on role and location. Visit our careers site to read more about the benefits reputed company offers. Inclusion and Accessibility reputed company is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request here. Are you a reputed company reputed company Employee? Please click here to apply Apply To This Job

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