Sr. Manager, TMF System Business Lead

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Responsibilities: Provide subject matter expertise in the utilization of clinical business systems to promote TMF process and regulatory compliance . Align with process owners to ensure utilization of our clinical business systems is conducted in accordance with established processes and procedures. Align within functional stakeholders to represent the end-user needs of TMF to the R&D IT organization including business strategy, business requirements, user testing, and implementation of new systems and enhancements. Collaborate with cross-functional teams, including global development operations, R&D IT, and vendors, to ensure that TMF processes are conducted efficiently and effectively. Provide final business, regulatory, and administrative approvals per applicable SOPs. Actively participate in multiple aspects of User Acceptance Testing including scenario planning, scripting, and coordination with business users. Create and maintain applicable process and workflow documentation, in collaboration with process owners and process leads. Serve as a point of contact for compliance related activities including clinical auditing, inspection readiness, preparedness and support, finding assessments, corrective and preventive action development and delivery, and data integrity and audit trails reviews. Collaborate with R&D IT organization for activities such as active management of super user network, troubleshooting issues across capabilities. Qualifications: Education/Degree(s): Bachelor's degree in a related field, such as life sciences, computer science, or business administration. Experience: Minimum of 7+ years of experience in clinical development operations, with a focus on eTMF. Preference to experience with project management methodologies and tools. Must have a strong understanding of the primary clinical business systems utilized for TMF process. Skills/Abilities: Excellent teamwork, interpersonal, and communication skills, with the ability to communicate and collaborate with employees and management at all levels and through various formats Demonstrated ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teams and to influence areas not under direct control to achieve objectives Strong analytical and problem-solving skills, with the ability to identify and resolve complex issues. Ability to work independently and manage multiple priorities in a fast-paced environment. Travel: Occasional 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. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.