Bristol-Myers Squibb
posted 2 months ago
At Bristol Myers Squibb, we are committed to transforming patients' lives through science, and this role is pivotal in achieving that mission. As a Study Start-up Senior Specialist, you will independently manage multiple country, study, and site-level deliverables during the start-up and maintenance phases of clinical trials. This includes collaborating with both internal teams and external business partners to ensure that all trial milestones are met efficiently and effectively. You will be responsible for planning and developing strategies for start-up activities, which are crucial for successful recruitment and timely delivery of trial objectives. Your role will involve preparing investigator sites to conduct clinical trials by reviewing and approving essential clinical trial and regulatory documents. You will support local regulatory teams in preparing submissions for Health Authorities, ensuring that all necessary documentation is submitted and followed up on until approval. This includes substantial amendments and any other documentation requiring Health Authority submission. Additionally, you will prepare and perform submissions for Ethics Committees, ensuring that all required documents are submitted and approved in a timely manner. Collaboration is key in this position, as you will work closely with internal study teams, external site staff, and country ethics committees to align tasks and priorities with defined study timelines. You will also be responsible for reviewing and approving Clinical Trial Package (CTP) documentation and ensuring that the electronic Trial Master File (eTMF) contains all relevant regulatory documents for site activation and ongoing study management. Your expertise will be essential in supporting Health Authority inspections and audit preparations, as well as in identifying innovative ways to enhance the start-up process and improve efficiency while maintaining high-quality standards. In this senior-level role, you will serve as a Subject Matter Expert (SME) for key investigational sites, documenting and maintaining relevant information about site structures, start-up processes, and key contacts. You will represent Bristol Myers Squibb in local working groups and meetings, proactively addressing local requirements and questions from Health Authorities and Ethics Committees. Your ability to analyze the start-up process and introduce efficiencies will be critical in speeding up timelines and ensuring successful trial outcomes.