Job description

Position: Clinical Database Programmer

Job Description Summary: Provides support to the Lead Data Manager and other study team members. Performs clinical database configuration/programming and database report development activities throughout the course of the study. This includes oversight of database build, data transfers, creation of system-to-system integrations, and generation of datasets for interim and final data analysis activities.

Responsibilities:

• Responsible for timely, complete, and accurate database project deliverables within the data management scope of services.
• Develop a draft study database using sponsor protocol and standards (if applicable) and existing Lexitas templates.
• Implement post-production changes necessitated by protocol amendments or program changes following database go-live based on documented post-production change documentation.
• Assist in the facilitation of database user acceptance testing.
• Assist in the facilitation of database validation.
• Oversee the issuance of queries and review query responses.
• Interact with internal study team members on database development and maintenance activities.
• Participate in client team meetings (as needed) as a technical resource concerning database development and maintenance activities.

Requirements:

· This position requires at least four years of hands-on clinical database programming/configuration experience, preferably in a CRO setting.

· Knowledge of Good Clinical Practices (GCP) and Good Clinical Data Management Practices (GCDMP).

· Relevant clinical database development experience inclusive of technical experience within and outside of Data Management.

· Experience with one or more commercial EDC platforms (IBM Clinical Development, Medrio, MedNet, Medidata RAVE, Datatrak). Experience in IBM Clinical Development is preferred.

· Competent computer skills including MS Office Suite.

· Experience with SAS is a plus.

· Experience with SQL a plus.

· Experience with CDISC data standards a plus.

Skills & Attributes:

· Customer service oriented.

· Demonstrated good communication skills (written and verbal).

· Attention to detail.

· Manner of interactions demonstrates an understanding of the value of developing positive relationships.

· Ability to resolve routine problems and elevate issues appropriately.

· Ability to work in a fast-paced environment that requires effective multi-tasking and the ability to easily adapt to changing priorities.

· Works well as part of a dynamic project team, actively supporting other team members.

· Ability to learn new things and assist others.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Application Question(s):

• What industries have you worked in?
• How many years of experience do you have in a CRO setting?

Work Location: Remote

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