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Clinical Data Architect

Clinical Data Architect

Summary Description

The Clinical Data Architect will contribute critical data analysis and reporting functions from designing information architecture and data-modeling processes to executing data requests for key stakeholders.

Detailed Description

DUTIES AND RESPONSIBILITIES

Duties include but are not limited to:

1. Create import and export programs in standard, client-specific, and CDISC compliant formats.

2. Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance.

3. Participate in internal/external audits and regulatory inspections as required.

4. Expand knowledge of SAS and relevant programming languages in the Clinical space.

5. Develop mapping specification for data exports in accordance with applicable standards.

6. Identify and develop new and improved components within CDM to meet client needs

7. Generate models and schemas to meet specific client needs

 

QUALIFICATIONS & SKILLS

Qualifications 

Minimum Qualifications:

1. B.S. in computer science, engineering, informatics, math, statistics, or equivalent experience

2. 5+ years’ experience in Clinical trials (or related healthcare field), programming, and data analysis

3. Solid understanding of SAS, CDISC, Software development, implementation architecture, project management

4. Demonstrate ability to learn new systems and function in an evolving technical environment

5. Strong organizational skills, ability to manage competing priorities, and flexibility to change

6. Business skills to gather stakeholder requirements and proactively identify solutions

7. Work effectively in a quality-focused, regulated environment

8. Passionate about the Science 37 mission

 

Preferred Qualifications:

1. Advanced degrees in engineering, computer science, informatics, math, statistics, or related technical field from a top tier university

2. Understanding of SAS, BRIDG, XML, SQL, Software development, implementation architecture, project management

3. Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application.

Location Playa Vista, CA

URL to Listing https://boards.greenhouse.io/science37/jobs/647391

Company Information

Contact Name Candace Ferruzza

Company Science 37

Phone Number 984-377-3737

Email candace@science37.com