Job Description
About USDM
USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what sets us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.
As part of the USDM team, you have the opportunity to work with cutting edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?
Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.
Nature and Scope of Job
USDM is seekingan experienced Medical Information System Specialist with deep, detailed, and hands-on expertise in IRMS. This role involves managing, configuring, and optimizing the IRMS system to support the medical information needs of our organization, ensuring compliance with industry standards and improving the efficiency of our medical information processes.
Primary Responsibilities
- Oversee the configuration, management, and daily operations of the IRMS system to ensure it meets the needs of the medical information team and other stakeholders.
- Collaborate with IT and other departments to integrate IRMS with other systems, ensuring seamless data flow and maintaining data integrity.
- Provide hands-on support to users, troubleshoot system issues, and conduct training sessions for staff to enhance their proficiency with the system.
- Customize the IRMS system based on business requirements, developing and implementing new features, workflows, and enhancements to improve its functionality and efficiency.
- Ensure that the system adheres to all regulatory and compliance requirements (e.g., FDA, GDPR), including managing data security, privacy, and audit trails. Generate and analyze reports to support regulatory submissions and business decisions.
- Maintain comprehensive system documentation, including user guides, technical specifications, and standard operating procedures (SOPs) for future reference and training.
- Stay updated on new features, updates, and best practices related to IRMS and medical information systems to continuously improve the system’s performance and user experience.
Qualifications
- 3-5+ years of experience working directly with IRMS from Anju Software, including system configuration, customization, and support.
- Strong knowledge of database management, data integration processes, and system administration. Familiarity with SQL and system APIs is a plus.
- Understanding of regulatory requirements (FDA, EMA, GDPR) and experience ensuring compliance in medical information systems.
- Proven ability to troubleshoot complex system issues, provide practical solutions, and implement changes quickly.
- Excellent communication skills to collaborate effectively with cross-functional teams and provide clear user support and training.
- High level of accuracy and attention to detail when configuring and managing the system to ensure data integrity and compliance.
Preferred Skills
- Experience in the pharmaceutical, biotech, or healthcare industries.
- Familiarity with other Anju Software solutions and integrations.
- Certification or training in medical information systems or database management.
Education Certifications
- Bachelor’s degree in Information Technology, Life Sciences, or related field.
Working Conditions
The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job, and are not meant to be all inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.
Unless reasonable accommodations can be made, while performing this job the staff member shall:
- Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
- Operate other office productivity machinery, such as a calculator, scanner, or printer.
- Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.
Equal Opportunity Statement
USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Disclaimer
This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Compensation
Salary/Hourly Rate Range (W2): USD 70.00 - 90.00
The base salary/hourly rate range represents the anticipated low and high end of the USDM’s compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as the candidate’s qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget.
Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage.Both full and part-time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan. Full and part-time employees may be eligible for paid time off.All employees are eligible for USDM's rewards and recognition program.
For more details about our benefits, visit us here:https://usdm.com/careers
