NAMSA

Lead business analysis, system design, implementation, and support in clinical data management environments. | 5-8 years experience in business analysis within GxP environments, expertise with EDC applications, and strong project management skills. | 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.

Manage clinical site monitoring activities, ensure compliance with regulations, communicate with study sites, and maintain study documentation. | Requires higher education, preferably 2 years clinical trial experience, knowledge of clinical research regulations, and good communication and organizational skills. | 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: • Works on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed. • Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines. • May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits. • Serve as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed. • Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns. • Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc. • Performs study-related training. • Manages the development and maintenance of study documents, processes and systems as assigned. • Ensures quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewals. • Tracks study site and over all study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance. • Attends internal and external meetings as required. • Provides all job-related progress reports and visit documentation as required. • May support safety activities such as narrative writing, managing the CEC/DSMB, etc. • OUS: Prepares and coordinates submissions to regulatory authorities. • May perform other activities as assigned. Qualifications & Technical Competencies: • Fluency in English and local language, if different, required. • Higher education degree or equivalent education, training, and experience. • Preferred 2 years clinical trial experience. • Preferred monitoring experience. • Able to work independently once trained. • Good verbal and written communication skills. • Strong organizational skills. • Basic computer proficiency. • Understanding of clinical research processes and regulations. • Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required Working Conditions: • Up to 20% travel for In-House Clinical Research Associates; up to 80% travel for Field Clinical Research Associates. • 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. • While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus. • Extensive use of a computer keyboard. NAMSA was founded on the principals of delivering quality customer service, conducting ourselves with integrity, respect for one another, open communication and collaboration. Whether you have a background in Laboratory Science, Clinical Research, Regulatory Affairs, Quality Assurance, Engineering, or Sales & Business, NAMSA offers exciting opportunities to align with your expertise.