The regulatory information systems team supports every office globally. The regulatory information systems manager role is a managerial position that will build and lead a team of uniquely skilled members who can do both the regulatory oversight work and the systems work on internal development and system implementations.
The successful regulatory information systems manager will:
• Provide Functional leadership and direction to the Regulatory Information Systems Department. Lead the development and execution of long-term technology & system strategies which support the regulatory oversight functions and research administration of the Center.
• Develop strong partnerships with the Institutional Review Office, Clinical Research Support Office, Office of Sponsored Research, Animal Health Resources, Environmental Health and Safety, Technology Transfer, SCCA Research Implementation, and other internal and external regulatory oversight partners to understand the Center's needs and deliver technical solutions to support initiatives.
• Act as a liaison between Center IT, external vendor(s), the Institutional Review Office, Clinical Research Support Office, and other regulatory oversight teams when developing and implementing technology solutions for regulatory oversight and research administration.
• Be responsible for applications, systems and data critical for the various regulatory oversight programs and research administration functions.
• Balance complex IT solutions versus business need to accomplish objectives in an economical and efficient manner.
• Establish 21 CFR Part 11 governance program and ensure adequate testing and documentation of impacted systems and programs.
• Responsible for overseeing the departmental budget and developing yearly budget plans.
• Manage the operations of the Regulatory Information Systems Department.
• Continually assess industry best practices and participates in relevant industry forums.
• Partner with IT Leaders across the Center to ensure compliance with all applicable enterprise and division specific policies, controls and standards; assess technology risks, driving mitigation plans and actions through process, policy, procedures and technical solutions, to reduce and eliminate vulnerabilities; drive adherence to the terms and conditions of individual grants and contracts, collaboration agreements and initiatives, and data/technology access and use requirements; lead business continuity and disaster recovery planning and testing for all systems/technologies within regulatory information systems.
• Bachelor's degree in computer science, information systems, systems analysis, or a related study. Master's degree is preferred.
• At least 5 years experience in regulatory information systems for organizations involved in Human Subjects research. At least 2 years in a leadership role.
• Track record of developing and implementing technology strategies within a large, complex organization.
• Specific experience in implementing regulatory oversight technology systems in an academic medical center environment. Experience with Clinical Trial Management Systems, Electronic Data Capture Systems and/or IRB Management software preferred.
• Technology project management experience.
• Experience in relational database design, modeling, and development.
• Experience with 21 CFR 11 compliance, with working knowledge of other core regulations governing human subject and animal research.
• Quality/Six Sigma expertise or certifications is highly desirable.
• Ability to work with end users to develop technology solutions that meet business needs.
• Knowledge of financial models and budgeting.
The successful candidate will possess the following attributes:
• Works well with others
• Ability to thrive in a diverse matrix environment, build consensus, and develop/nurture key relationships and support laterally across business lines.
• Positive influencing skills both verbally and through the preparation of written materials.
• Exceptional interpersonal skills, including teamwork, facilitation, and negotiation.
• Excellent written and verbal communications skills.
• Displays intellectual integrity.
• Ability to convey a clear course and sense of direction and understanding of the external/internal environments.
• Motivated by the long term. Results driven, ensuring short-term goals are achieved that support long-term initiatives with an appropriate sense of urgency.
• Honed analytical skills focused on problem solving and process improvement in a rapidly changing environment.
• Ability to work with a high energy level in an unstructured, fast-paced and often ambiguous work environment, and navigate organizational structures with sensitivity and finesse.
• Strong planning and organizational skills.
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