Line Head, eTMF Specialist

This is a supervisory position responsible for overseeing a team of eTMF Specialists, who are accountable for document upload and management in the electronic Trial Master File (eTMF) to support BMS Clinical Trials. As the supervisor, you will manage the allocation of workload among the team, ensuring tasks are completed efficiently and accurately. Your role involves overseeing the upload and quality reviews of electronic documents in the eTMF system to guarantee they are inspection-ready and compliant with the ICH/GCP and ALCOA Plus principles. You will be responsible for training and supervising the team to ensure they accurately complete attributes, metadata, and workflows for uploaded documents, enabling proper classification, management, identification, and accessibility for retrieval. Additionally, you will actively manage and develop direct reports by setting annual objectives, conducting mid-year and end-of-year evaluations, and providing necessary training on eTMF, procedural documents, and Health Authority regulations. Collaboration with various functions supporting clinical trial processes is essential to ensure regulatory requirements for maintaining compliant TMFs are met and to identify efficiency opportunities. Your responsibilities will also include maintaining knowledge of regulatory requirements and industry trends related to TMF compliance, addressing compliance gaps highlighted by Quality metrics and KPIs, and leading continuous improvement initiatives related to clinical trial documentation and TMF compliance. You will undertake remediation and training as needed to ensure eTMF documents meet user/requestor requirements. To qualify for this role, you must have a minimum of a bachelor's degree in Life Science, Business Administration, or equivalent experience, with an advanced degree being a plus. You should have 5-7 years of experience in health sciences or a related industry, including supervisory responsibility for eTMF. Strong knowledge of TMF, eTMF, and clinical document management systems, particularly Veeva Vault eTMF, is required. Proficiency in Excel, PowerPoint, SharePoint, and creating reports and dashboards in eTMF is essential. Comprehensive knowledge of local and international regulatory guidelines relevant to TMF Management is expected, along with the ability to provide TMF-related training and coaching to stakeholders. You should be well-versed in ALCOA Plus standards, Good Clinical Practice, Good Documentation Practices, and ICH guidelines. Experience in managing, leading, and developing employees, as well as collaborating with peers, is necessary. Additionally, you must possess strong organizational, technical, analytical, problem-solving, and critical thinking skills. Excellent communication and interpersonal skills are crucial for interacting effectively at all levels of the organization. Strong leadership, people management, time management, and project management skills are required. You should be adaptable, proactive, and motivated for continuous learning and organizational development, with a keen interest in quality review processes and decision-making.,