**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 rich in diversity. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, cell therapy, immunology, fibrosis and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. The Senior Manager, Clinical Data Management (Data Management Lead) is a role considered essential to the sustainability and success of the BMS R&D pipeline. This role reports to the Director, Clinical Data Management or Associate Director, Clinical Data Management (Line Manager) within the Global Data Management and Centralized Monitoring function of Global Development Operations (GDO). This is an office-based position at BMS office at Princeton/Lawrenceville NJ, Princeton Pike NJ, San Diego CA, Seattle WA, or Boudry Switzerland This strategic role is responsible for: **Project Management and Leadership** + Provides clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects + Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects + Responsible for end to end clinical data management activities and serves as a primary point of contact for internal and external study team members + Provides strong quality and project oversight over third party vendor responsible for data management deliverables + Takes a leadership role to gather content and integration requirements for EDC and close collaboration with partners supporting other data collection systems (eCOA, External Data, Safety Gateway). Enforces data standard conventions and quality expectations for clinical data per defined processes + Authors, reviews/revises DM related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization + Chairs Data Quality Review meetings with cross functional study team members to ensure on-going review of trial data currency , quality and completeness + Represents DM on cross-functional project teams & submission Teams + Lead or support the Health Authority inspections and audits + Provides coaching and quality oversight of junior Data Management Leads **FSP/CRO/Vendor Oversight** + May act as core member of the study team and provides FSP/CRO/Vendor oversight for end-to-end Data Management activities, manages data currency throughout the trial, and overall monitoring DM deliverables according to the Service Level Agreement (SLA) **Continuous improvement initiatives** + Lead/provide the relevant support and input to continuous improvement activities within clinical data management + Provides support for CAPA implementation as required **Experience and Expertise Required** + Bachelor's degree required with an advanced degree preferred. + At least 5 years of relevant industry experience. + Project management certification (e.g. PMP) is desirable. + Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors + Sound knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management + Strong knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills and well versed in industry trends and emerging technologies supporting data collection + Strong project management; Exhibits expertise in metrics analysis and reporting methodologies + Excellent oral and written communication skills + Communicate effectively with senior management and cross-functional teams + Knowledge of submission requirements, [e.g. New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA)] **Travel Requirements** + 5-10% Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed) **Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.** **Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.** 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 an inclusive culture, promoting diversity 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 a diverse 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 adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility 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. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. **Company:** Bristol-Myers Squibb **Req Number:** R1587010 **Updated:** 2024-12-26 03:26:57.427 UTC **Location:** Princeton-NJ Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.