NAMSA

Develops and supports business systems, participates in process improvements, and manages system deployment activities. | Requires 2-5 years of experience in business analysis or related discipline, with skills in system configuration, project management, and technical documentation. | This a Full Remote job, the offer is available from: California (USA), Georgia (USA), Minnesota (USA), Ohio (USA) 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: • Develops Business analysis, design, configuration, coordination, implementation and support. • Develops specific system deployment activities that include the following: functional requirements definition, detailed technical design, system configuration, conversion and integration requirements, unit testing, systems test, acceptance test, go-live, and production turn over. • Participates in 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. • Actively participates 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. • 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. • Performs other duties as assigned. Qualifications & Technical Competencies: • Bachelor’s Degree in Computer Science, Information Technology, Business Administration or related discipline required. MBA or Advanced degree a plus. • 2-5 years’ experience in computer systems, business, analyst or related discipline preferred. • Proven experience in software development life cycle, including business process and requirements documentation, analysis, design, system construction, testing, training, communication planning and deployment (concept to deployment). • Proven experience configuring packaged, integrated systems. • Hands on experience in gathering, documenting, and communicating project business and application architecture requirements using Microsoft Word, PowerPoint, Excel, Visio, and other appropriate software. • Proven customer service/user support skills and experience in working with NAMSA business unit areas as well as in working with and directing vendor support personnel. • Ability to manage multiple tasks and manage small to large projects in a cross-functional, global environment. • Demonstrated experience in implementing and supporting integrated, enterprise 3rd party packaged software and cloud solutions. • Demonstrated working knowledge of systems supporting business processes. • Must have strong interpersonal skills, be self-motivated, have strong desire to learn, and be adaptable to a fast paced, ever-changing environment. • Operational and technical knowledge of the assigned business unit. • 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: $54,400.00 Pay Range Target: $80,000.00 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. Fair Chance Employment Statement: At NAMSA, we are committed to providing equal employment opportunities to all qualified applicants, including those with arrest or conviction records. In accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act, we will consider qualified applicants with a criminal history. Please note that NAMSA conducts a review of criminal history after the interview process and offer acceptance. This review is conducted to ensure that there is no direct, adverse, or negative relationship between the criminal history and the material job duties of the specific position. The following is a list of material job duties for this position: • May operate equipment • Records data timely and accurately • May analyze and interpret data • Conducts studies on medical devices that have an impact on human life A criminal history that directly impacts the ability to perform these duties may result in the withdrawal of a conditional offer of employment. We believe in fair chance hiring and are committed to evaluating each applicant on a case-by-case basis. This offer from "NAMSA" has been enriched by Jobgether.com and got a 75% flex score.

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.