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Clinical Business Systems Lead

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Job Details

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 .

Job Title: Clinical Business Systems Lead, Global Trial Management

Job Summary: We are seeking a highly skilled and experienced individual contributor to join our team as a Clinical Business Systems 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 functions. This clinical business systems lead will be representing the end-user needs of the global development operations organization to the R&D IT organization.

Key Responsibilities:
  • Provide subject matter expertise in utilization of clinical business systems that support clinical development operations, including clinical trial management, site management and monitoring, data management, and regulatory compliance.
  • Understand clinical business systems and capabilities for your respective GDO function, including but not limited to: flexible site engagement, external data acquisition, global data management, and electronic data capture (EDC), clinical trial management systems (CTMS), and Trial Master File (eTMF), SPOT lite.
  • 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 functions to represent the end-user needs of global development operations 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, IT, 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 clinical development operations 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
  • Collaborate with R&D IT organization for activities such as active management of super user network, troubleshooting issues across capabilities
  • Where a capability spans multiple user groups or functions, facilitate the collection of business and user requirements
Qualifications:
  • Bachelor's degree in a related field, such as life sciences, computer science, or business administration.
  • Minimum of 5 years of experience in clinical development operations, with a focus on clinical trial management, data management, and regulatory compliance.
  • Aligned with GDO functions and process owners, must have a strong understanding of the primary clinical business systems utilized by their functions, including but not limited to flexible site engagement platforms, EDC, CTMS, SPOT, MS Project and eTMF and more
  • 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 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/ 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.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.