Senior Manager, TMF System Business Lead

This position provides subject matter expertise in clinical business systems supporting TMF processes, working closely with process owners, leads, and functional stakeholders to ensure systems are fit for purpose to represent the needs of end users, and are operated according to established procedures. To support these aims, this position is responsible for creating and maintaining process documentation, supporting compliance activities such as internal business monitoring, clinical auditing, and inspection readiness, and managing system-related issues with members of the TMF team and in collaboration with broader R&D, including Global Development Operations, R&D IT, and associated vendors and consultants, to deliver efficient and effective TMF processes.

Duties/Responsibilities:

• Provide subject matter expertise in the utilization of clinical business systems to promote TMF process and regulatory compliance.
• Align with process owners to ensure utilization of our clinical business systems is conducted in accordance with established processes and procedures.
• Align within functional stakeholders to represent the end-user needs of TMF 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, R&D IT, and vendors, to ensure that TMF processes are conducted efficiently and effectively.
• 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.
• Create and maintain applicable process and workflow documentation, in collaboration with process owners and process leads.
• Serve as a point of contact for compliance-related activities including clinical auditing, inspection readiness, preparedness and support, finding assessments, corrective and preventive action development and delivery, and data integrity and audit trails reviews.
• Collaborate with the R&D IT organization for activities such as active management of the super user network and troubleshooting issues across capabilities.

Reporting Relationship:

Reports to the TMF Compliance Lead

Qualifications:

Education/Degree(s):

• Bachelor's degree in a related field, such as life sciences, computer science, or business administration.

Experience:

• Minimum of 5 years of experience in clinical development operations, with a focus on eTMF.
• Preference for experience with project management methodologies and tools.
• Must have a strong understanding of the primary clinical business systems utilized for TMF process.

Skills/Abilities:

• Excellent teamwork, interpersonal, and communication skills, with the ability to communicate and collaborate with employees and management at all levels and through various formats.
• Demonstrated ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teams and to influence areas not under direct control to achieve objectives.
• 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.

Travel:

Occasional