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.
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.
Job Summary: We are seeking a highly skilled and experienced individual contributor to join our team as a Systems and Process Lead. In collaboration with functional subject matter experts, this role provides expertise in clinical development operations requirements, assigned clinical business systems, and alignment with process owners. Embedded within the GDO/GDM functions, the role serves as the primary voice of Global Data Management to the Drug Development BI&T and other teams as appropriate
Key Responsibilities:
- Provide subject matter expertise in utilization of clinical business systems that support clinical development operations, focused on Global Data Management (GDM) and regulatory compliance.
- Understand clinical business systems and capabilities for Global Data Management, with a focus on electronic data capture (EDC), external data acquisition, clinical data review, medical coding , electronic clinical health outcome (eCOA), and Dashboards.
- Drive the operation and continuous enhancement of EDC URLs, serving as the accountable business owner and technical expert with evolving business needs.
- Support the development and execution of automation, innovation, and digital data capture strategies which may include eSource technologies, decentralized clinical trials (DCT) and mHealth.
- Act as Process Lead and align with process owners to ensure that utilization of our clinical business systems is conducted in accordance with established processes and procedures.
- Align within GDM functions to represent the end-user needs of Global Data Management (GDM) to the Drug Development BI&T organization including business strategy, business requirements, user testing and implementation of new systems and enhancements.
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- Actively participate in multiple aspects of User Acceptance Testing including scenario planning, scripting, and coordination with business users
- Collaborate with cross-functional teams (GDO, BI&T etc) and vendors to ensure that clinical development operations are conducted efficiently and effectively.
- Stay up to date with industry trends and best practices in the utilization of business systems.
- Provide input on training content and learning management systems curriculum
- Provide final business, regulatory, and administrative approvals per applicable SOPs
- In collaboration with process owners and process leads, create and maintain any applicable process and workflow documentation
- Serve as a point of contact for compliance related activities including inspection support, corrective and preventive actions, data integrity and audit trails reviews
- Where a capability spans multiple user groups or functions, facilitate the collection of business and user requirements
- Proactively resolve technical and process issues with cross functional teams to drive process optimization and operational efficiency.
- Leads initiatives with broad, cross-functional impact (including strategic process and technology improvements), influencing direction and driving to completion
- Developing strong and productive working relationships with key stakeholders throughout GDM, GDO and BMS to drive results and remove barriers to execution.
Qualifications:
- Bachelor's degree in related fields, such as life sciences, computer science, or business administration.
- Minimum of 5 years of experience in clinical development operations, with a focus on clinical data management and regulatory compliance.
- Must have a strong understanding of the process and primary clinical business systems, utilized by their functions (EDC, data acquisition, data review and eCOA platforms).
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
- 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.
- Experience with project management methodologies and tools is a plus.
- If you meet the above qualifications and are passionate about global development operations, we encourage you to apply for this exciting opportunity.
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.
Supporting People with Disabilities
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/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
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/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
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