Business System Analyst, Clinical Data Management

North American Science Associates • Atlanta, OH

1d

About The Position

NAMSA, a pioneer in the medical device industry, was the first independent company globally to focus solely on medical device materials for safety. Established before the U.S. Food and Drug Administration began regulating such products in 1976, NAMSA has significantly contributed to the development of industry test methods and is recognized as a premier provider, supporting clients throughout the product development lifecycle. The company's vision is to inspire innovative MedTech solutions that advance global healthcare, improve patient lives, and accelerate client success, driven by a mission to deliver best-in-class global MedTech development solutions through its people, expertise, and technology, while adhering to core values of integrity, customer experience, talent development, agility, and collaboration. This role involves leading business analysis, design, configuration, coordination, implementation, and support for business systems, with a focus on system development and deployment activities, process improvements, and enterprise-wide change management.

Requirements

• Bachelor’s Degree in Computer Science, Information Technology, Business Administration, Clinical Data Science, or related discipline required.
• 5 - 8 years’ experience in computer systems, business, analyst within a GxP environment.
• Ability to listen and encourage thoughts, opinion and discussions where needed
• Expert customer service/user support skills and experience in working with Clinical Data Management, Core Lab, and Safety stakeholders as well as in working with and directing vendor support personnel
• Excellent follow through, ability to develop and implement action plans and possession of issue resolution
• Excellent relationship management skills and driving timely and effective decision-making
• High degree of professionalism and a project management style that promotes progress through teamwork in a collaborative environment.
• Proven experience in developing innovative solutions
• Proven experience configuring EDC applications such as Zelta or Mednet and integrating EDC data to CTMS systems or Data Lake solutions.
• Strong interpersonal skills and ability to solicit participation and input from others
• Strong Facilitation and meeting management skills
• Operational and technical knowledge of Zelta, Mednet, or other similar EDC systems.
• Understanding of both waterfall and agile project methods

Nice To Haves

• MBA or Advanced degree preferred.

Responsibilities

• Leads Business analysis, design, configuration, coordination, implementation and support.
• Leads specific system development and deployment activities that include the following: functional requirements definition, conceptual design, logical design, detailed technical design, system configuration, conversion and integration requirements, unit testing, systems test, acceptance test, go-live, and production turn over.
• Leads process improvements including, formulation and definition of technical scope and objectives of project, analysis of current business practices, processes, and systems, define detailed project tasks, and participating on a matrix team to execute projects.
• Contributes in enterprise-wide change management processes for requested system revisions.
• Provides escalated technical support for enterprise client areas on existing business systems.
• Tracks and addresses bugs identified in testing and production.
• Facilitates various Agile processes such as Iteration / Release Planning, Backlog Refinement, Retrospective, Sprint Review, Daily Stand-up
• Conceptualizes new processes and systems that add value to NAMSA business units.
• Provides user stories to multi-disciplinary teams and define the business-driven acceptance criteria.
• Proactively engages technical Associates to schedule and execute required tasks.
• Cultivates and maintains successful relationships between Information Technology team and Associates from various NAMSA organizations globally.
• Documents system for turnover and training of NAMSA Associates, Information Technology peers, and Service Desk.
• Effectively designs system architectures for technical solutions.
• Creates and manages the implementation of technical solutions.
• Responsible for ensuring that IT controls are implemented and maintained.
• Responsible for ensuring that operational documentation is created and maintained.
• Manages complex implementation projects and enterprise wide network and system projects.
• Provide subject matter proficiency in specific functional area(s) to the assigned Scrum team
• Performs other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1-10 employees