What are the responsibilities and job description for the Clinical Data Analyst position at Viltis?
Job Title: Clinical Data Systems Analyst II
Location: Sylmar, CA
Hours: Business Hours
Onsite/Remote: Initially onsite; potential for hybrid after performance evaluation
Duration: 12-month contract with potential for extension
Interview Process: Two managers will conduct interviews, either together or separately
Job Summary:
Working under general supervision, the Clinical Data Systems Analyst II will be responsible for special projects related to the data systems used in clinical studies. This includes implementing, updating, and enhancing systems for clinical data collection while supporting global internal and external customers. The role requires collaboration with the Clinical Affairs Organization, Data Management, and Systems Development teams to ensure data integrity and compliance with regulatory standards.
The ideal candidate must have strong experience in Software User Acceptance Testing (UAT) and the Software Development Life Cycle (SDLC), along with proficiency in database management systems and clinical trial technologies.
Key Responsibilities:
- Conduct and coordinate Software User Acceptance Testing (UAT) to verify business requirements.
- Develop and execute user stories, test plans, test cases, and scenarios (e.g., using Jira or Azure DevOps).
- Maintain software documentation, including system specifications, validation plans, and requirements.
- Collaborate with stakeholders to define business needs and support software development.
- Provide end-user support, troubleshooting, and issue resolution (SQL knowledge preferred).
- Analyze user requirements, document project specifications, and lead discussions on system updates.
- Lead or support Clinical Trial Management Software (CTMS) projects and enhancements.
- Manage multiple projects and prioritize work effectively in a fast-paced environment.
- Deliver training sessions on application usage and provide ongoing user support.
- Ensure compliance with Good Clinical Practices (GCP), FDA regulations, ICH, ISO 14155, and other regulatory requirements.
Required Qualifications:
- Bachelor’s degree in Computer Science, Health Sciences, Business, or related field (or equivalent experience).
- Minimum 3 years of experience in clinical research, healthcare, or life sciences industry.
- Strong organizational and project management skills, with attention to detail.
- Proficiency in MS Office (Word, Excel, Access) and experience with Oracle databases.
- Knowledge of relational databases, ability to write SQL queries, and troubleshoot data issues.
- Hands-on experience with clinical trial database development (e.g., Oracle Clinical, RDC).
- Understanding of Clinical Trial Management Processes, EDC systems, and regulatory requirements.
- Excellent communication and stakeholder management skills.
- Ability to work independently and collaboratively in a highly matrixed environment.
Preferred Qualifications:
- Experience working with clinical data collection tools (EDC) and Clinical Trial Management Software (CTMS).
- Background in SaaS for clinical studies or similar regulated industries.
- PMP certification or experience with formal project management methodologies.
- Prior experience supporting global clinical studies and handling multiple stakeholders.
- Experience leading or supporting system validation activities for regulated environments.
Why Join Us?
- Opportunity to work on innovative projects in clinical data systems and software solutions.
- Exposure to cutting-edge technology in clinical trial management.
- Collaborative work environment with opportunities for professional growth.
- Potential for contract extension based on performance.
This job description will be reviewed periodically and is subject to change by management.
NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law, including disability/veteran status. This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company’s facilities.
Here is a link to the Job Description on our company website:
https://careers.bioethic.co/#/jobs/195