Sr. Manager, Business Operations 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.

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Job Summary

We are seeking a highly skilled and experienced individual contributor to join our team as a Business Operations Lead. The successful candidate will be responsible for providing, in conjunction with functional subject matter experts, expertise in clinical development operations requirements, understanding of assigned clinical business systems, aligning with process owners, and embedded within the respective GDO/GDM functions. This Business Operations Lead will be representing the end-user needs of the global data management organization to the Drug Development BI&T organization.

Key Responsibilities

• Provide subject matter expertise in utilization of clinical business systems that support clinical development operations, focused on Global Data Operation (GDO), 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 and electronic clinical health outcome (eCOA).
• 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.
• Align with process owners to ensure that utilization of our clinical business systems is conducted in accordance with established processes and procedures.
• Align within respective GDO and 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.
• Collaborate with cross-functional teams 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
• Actively participate in multiple aspects of User Acceptance Testing including scenario planning, scripting, and coordination with business users
• 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.

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.