CDISC Subject Matter Expert

Overview

CDISC Subject Matter Expert

US Remote

The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee - from entry level through top executive - to contribute to our clients' success by sharing ideas openly and honestly.

Primary Purpose

This position supports "Essex, a Veridix AI company". Essex is a biomedical informatics and health information technology-focused consultancy founded in 2009 and headquartered in Rockville, MD. The Essex team comprises experts with extensive experience in strategically developing and managing complex health and biomedical information programs for clients in the Federal Government, research academia, and private sectors.

The Subject Matter Expert (SME) demonstrates advanced knowledge and technical capabilities in the design and implementation of Health Information Technology (HIT) systems, clinical database architectures, semantic infrastructures, and/or data standards associated with healthcare or clinical data.

Responsibilities

• Advising project teams on adoption of architectures or data standards
• Assess customer needs and advise on solutions based on requirements
• Provide services to develop scalable and regulatory compliant data architectures and systems
• Lead tasks as required in order to fulfill project objectives

Qualifications

• Deep knowledge of clinical and health information technology standards relevant to client project - such as HL7, CDISC, DICOM, RM-ODP, 21 CFR Part 11, etc.
• Deep knowledge of relational databases pertinent to the delivery of regulatory compliant technology solutions
• Bachelor's Degree in relevant field and 20+ years of experience required; or master's degree and 10+ years of experience required; or Ph.D. / MD (preferred)
• Certifications in relevant technical disciplines highly preferred
• Leadership role in professional organizations and/or standards bodies highly preferred
• Work for this position must be performed in the United States (required). Candidates local to Rockville, MD are preferred.
• Applicants selected for this position will be subject to a government security investigation and must meet eligibility requirements for Public Trust positions. Visa sponsorship is not available.
• Successful applicants will be required to travel to an NIH-designated facility for security badging within 60 days of hire. Expenses will be reimbursed.

Emmes requires all US based Clinical Research Associate new hires to be fully vaccinated before their first day of employment. All new hires may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. Emmes complies with all applicable laws regarding reasonable accommodations or exemptions for religious, medical, or other legally protected reasons.

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

• Flexible Approved Time Off

• Tuition Reimbursement

• 401k Retirement Plan

• Work From Home Anywhere in the US

• Maternal/Paternal Leave

• Casual Dress Code & Work Environment

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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.