Acts as the main point of contact for a country with global study team members and accountable for the coordination with local country cross functional teams. Implements the local country and site feasibility process, including proposal and validation of country study targets, as endorsed by country leadership. Plans, develops and executes timelines and activities for start-up in collaboration with the local study team, Global Trial Acceleration Centre (GTAC) and other relevant stakeholders. Implement country and site level patient recruitment strategy and risk mitigation. Coordinates and ensures country level study enrolment targets and timelines are met in collaboration with relevant stakeholders. Leads problem solving and resolution efforts including management of risk, contingencies, issue resolution and escalation to the appropriate stakeholder/s. * Assessment and set up the of vendors during study start up period (locally) Investigator Meeting participation and preparation. Ensures data entered in the Clinical Trial Management System (CTMS) is current and complete, and access to eDC and vendor systems is available for the country and clinical trial site personnel. This includes entering necessary data and uploading documents in eTMF. Validation of study related materials (i.e. protocol, ICF, patient material). Supports the review of country and site-specific documents (e.g. ICF, patient material), and where applicable may include the preparation of site level ICF and other documents. May support preparation of materials for Site Initiation Visits. * Responsible for verifying and confirming with local team eTMF completeness (Country and Site level). Prepare investigator sites to conduct clinical trials through verifying acceptability of Clinical Trial Package (CTP) documentation. All rights reserved. Acknowledges Site Monitoring visit reports, takes action within the timelines specified and escalates issues and ensures appropriate documentation of issues. Coordination of database locks and query follow up. Ensures timelines are met. Ensure inspection readiness of assigned trials within country. Provide support to Health Authority inspection and pre-inspection activities. Coordinates and completes the Corrective Actions / Preventive Actions (CAPA) and ensures implementation for Country audit level findings. Drives CAPA review, implementation and completion. Bachelor's or master's degree required. Field of study within life sciences or equivalent Senior Clinical Trial Manager: At least 6 years of industry-related experience. Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiative Serve as a key resource for colleagues, by providing guidance, leading training and mentoring to other peer team members through a mentoring process using informal and/or formal presentations. Serve as a Subject Matter Expert (SME) in areas such as therapeutic area, systems or processes across the department with the opportunity to contribute at a regional or global level with this expertise. Deep understanding of GCP, ICH Guidelines and other local guidance, regulation and codes of practice related to Clinical Research and Medical Affairs Knowledge and understanding of clinical research processes, regulations and methodology Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management Demonstrated organizational and planning skills and independent decision-making ability Strong organizational and time management skills and ability to effectively manage multiple competing priorities Interpersonal, oral and written communication skills to influence, inform or guide others Good verbal and written communication skills (both in English and local language). Software that must be used independently and without assistance: Microsoft Suite CTMS eDC eTMF Travel Required (nature and frequency) - Occasional local travel requirement < 1 month/quarter An Office set-up Ergonomic desk requirement in office and at home If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients' lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. 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