Clinical Business Systems Lead

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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.

• Understand clinical business systems and capabilities for your respective GDO function, specifically Regional Clinical Operations, with a focus on flexible site engagement and clinical trial management systems (CTMS).

• 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 and CTMS.

• 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.

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