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NAMSANA

Business System Analyst, Clinical Data Management

NAMSA (North American Science Associates) is a leading global MedTech Contract Research Organization (CRO) that provides comprehensive services to medical device and diagnostics manufacturers, from testing and clinical research to regulatory and quality consulting.

NAMSA

Employee count: 1001-5000

Salary: 84k-110k USD

United States only

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NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.

We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry’s premier provider. We provide support for clients during every step of the product development lifecycle and beyond.

Come and work for an organization with the:

Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the

Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core

Values:

  • Act with integrity in everything we do.
  • Provide best-in-class customer experiences.
  • Develop superior talent and deliver expertise.
  • Respond with agility and provide timely results.
  • Embrace collaboration, diverse perspectives and ideas.

Job Description:

•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.

Qualifications & Technical Competencies:

• Bachelor’s Degree in Computer Science, Information Technology, Business Administration, Clinical Data Science, or related discipline required. MBA or Advanced degree preferred.
• 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

Working Conditions:

• Travels 20-30%.

• Requires occasional international travel.
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Extensive use of computer keyboard.

Pay Range Minimum:

$83,500.00

Pay Range Target:

$110,000.00

Pay Frequency:

Annual

Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills.

NAMSA is an equal employment opportunity company.

NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.

About the job

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Posted on

Job type

Full Time

Experience level

Salary

Salary: 84k-110k USD

Education

Bachelor degree

Experience

5 years minimum

Experience accepted in place of education

Location requirements

Hiring timezones

United States +/- 0 hours

About NAMSA

Learn more about NAMSA and their company culture.

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At the heart of North American Science Associates (NAMSA) is a deeply ingrained culture dedicated to advancing global healthcare and improving patient lives. Since its humble beginnings in 1967 as a small medical device testing lab, NAMSA has evolved into the world's leading MedTech Contract Research Organization (CRO), driven by a mission to provide best-in-class global development solutions. The company's ethos is built upon a foundation of core values that guide every action and decision: acting with integrity, providing best-in-class customer experiences, developing superior talent to deliver expertise, responding with agility to provide timely results, and embracing collaboration and diverse perspectives. This value system is not just a corporate statement but a living part of the organizational fabric, embodied by a team of over 1,800 dedicated associates worldwide. These scientists, engineers, clinical experts, and regulatory specialists are united by a shared passion for making a meaningful difference in the world by helping to bring life-saving and life-changing medical technologies to market safely and efficiently.

The culture at NAMSA is one of partnership and strategic guidance. They don't just see themselves as a service provider but as an integral extension of their clients' teams. This collaborative spirit is crucial in navigating the complex and ever-evolving landscape of medical device development. By offering a full continuum of services—from initial concept to post-market surveillance, including comprehensive testing, clinical research, and regulatory consulting—NAMSA fosters an environment of innovation and problem-solving. The company believes its potential begins and ends with its associates, actively seeking the brightest minds in the industry to join their mission. This focus on talent and expertise ensures that they can tackle the most intricate challenges in MedTech, from cardiovascular and orthopedic devices to in-vitro diagnostics and digital health. Ultimately, NAMSA's culture is a narrative of purpose-driven growth, scientific excellence, and an unwavering commitment to accelerating client success and, most importantly, enhancing patient safety and well-being across the globe.

Employee benefits

Learn about the employee benefits and perks provided at NAMSA.

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Paid Maternity Leave

Offers paid leave for new mothers.

Paid Paternity Leave

Offers paid leave for new fathers.

Flexible working hours

Provides flexible work time options.

Relocation services

Offers relocation assistance for new hires.

View NAMSA's employee benefits
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NAMSA

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