JOB OVERVIEW

Manage the implementation and functionality of clinical application configurations. Liaise with internal and external clients regarding the standardization and consistency of systems use. Coordinate the integration of new configuration requirements, features, and functionalities, and participate in the rollout of new product releases. Oversee staff of Clinical Systems Specialists, as needed.

QUALIFICATIONS:

• Bachelor’s Degree required: preferably in Health Information Management/Informatics, Biological Sciences, or other Health-related field.
• Seven years of related clinical research experience including four years of experience in a clinical systems environment.
• Equivalent combination of education, training, and experience.
• Advanced working knowledge of clinical electronic data capture systems and/or processes, applicable SOPs and regulations, and understanding of system interactions/interdependencies.
• Sound knowledge of clinical research terminology and procedures.
• Knowledge and ability to work cross-functionally and globally with an understanding of the IQVIA project team structure; ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Computer literacy required, including well-developed skills across the MS365 application suite (Excel, MS Access, MS Word, SharePoint, Teams) and willingness to acquire working knowledge of more advanced data analysis tools.
• Demonstrated aptitude for independent problem-solving.
• Effective organizational, communication, and writing skills.
• Customer management skills with good customer focus.
• To be eligible for this position, you must reside in the same country where the job is located.

ESSENTIAL FUNCTIONS:

• Manage study configuration for clinical applications supporting clinical trial services.
• Gather and document configuration-related business requirements from operations, clinical, sales, and customers for new studies and changes to existing studies.
• Evaluate the feasibility of study configuration requirements based on existing application capabilities.
• Collaborate with Operations, Clinical, and Customers to obtain approval/sign-off on study configuration requirements.
• Coordinate across Development, Product Management, Operations, and Clinical to prioritize and allocate time/resources to implement study configurations; manage change control for system modifications and enhancements after initial deployment.
• Collaborate with Tech Development to establish study-specific functional, integration, and performance specifications.
• Use application interface system admin role to apply and alter study-specific configurations.
• Collaborate with Data Management and Tech Delivery to map study-specific data taxonomy to clinical application databases.
• Produce, update, and distribute reports enumerating study configuration details.
• Collaborate with QC Testing team to address testing outcomes and validate study configurations.
• Communicate to Operations and Clinical regarding system release milestones and production-deployment readiness in preparation for SIV and FPI.
• Establish processes and author SOP/WI documentation for study configuration activities, including templates (e.g., Configuration Requirements, Change Requests) and other deliverables related to SDLC and CSV (Computer Systems Validation).
• Ensure the overall content of end-user training materials and user documentation corresponds with business requirements and system functionality, collating feedback from trainees to make improvements as appropriate.
• Collaborate with Product Management and Development to incorporate new product features into the study implementation process, assessing potential for integrating new features into existing study configurations.
• Coordinate with Product Owners to create training manuals/programs for new products and features, and with Operations and Clinical on operational readiness/training for using new products/features.
• Collaborate with Product Owners, Development, and QC Testing to incorporate automation methods and other tools to enhance the efficiency of the study configuration process.
• Work with support (help desk) staff during application deployment and maintenance phases to ensure users’ inquiries can be addressed efficiently.
• May participate in marketing activities, client presentations, and proposal development.

MANAGERIAL DUTIES INCLUDE:

• Manage staff in accordance with the organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work, appraising performance and guiding professional development, rewarding and disciplining employees, addressing employee relations issues, and resolving problems. Approve actions on human resources matters.
• Train, support, and supervise Clinical Systems Specialists; provide guidance on customer focus (both internal and external), maintaining motivation, and ensuring staff retention.
• Track the allocation of resources and monitor utilization to ensure departmental and corporate standards are met; participate in the HR hiring process including review of potential candidates and interviewing process.
• Conduct QC of consistency and validity of projects set up in designated collaboration systems.
• Facilitate communication among the Clinical Systems Specialists to share best practices, plan resources, discuss difficult issues, etc.