USA_Analyst, EDC Database Validation

Company: Mindlance
Location: Irvine
Posted on: August 7, 2022

Job Description:

Duties:

Develop moderately complex test scripts, review test scripts with data managers, and prepare test plans and reports for database validation and/or user acceptance testing to ensure accuracy of database structure and appropriate data is collected with proper validation.

Identify validation issues and partner with stakeholders (e.g., programmers, data managers, and data coordinators) to address and resolve issues.

Execute validation scripts for clinical reports.

Serve as a supporting programmer to the Lead programmer

Design, create, validate, and modify moderately complex clinical databases, and tools and programs for data validation checks, and clinical trial reporting according to company standards and specifications.

Assist in creating clinical listings and reports for data managers.

Author and execute validation scripts in partnership with team members.

Substantial knowledge and understanding of policies, procedures, and guidelines relevant to EDC (Electronic Data Capture) validation.

Substantial knowledge of processes and procedures in clinical data management.

Substantial knowledge of relational databases, systems, and programming languages.

Validation experience highly desired.

Skills:

Study Build experience with Medidata RAVE or other commercially available EDC systems is required.

Proven expertise in Microsoft Office Suite.

Basic project management skills.

Good written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills.

Excellent problem-solving and critical thinking skills.

Proven expertise in Microsoft Office Suite

Basic project management skills

Good written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills

Excellent problem-solving and critical thinking skills

Substantial knowledge and understanding of policies, procedures and guidelines relevant to EDC (Electronic Data Capture) validation

Substantial knowledge of processes and procedures in clinical data management

Substantial knowledge of relational databases, systems, and programming languages

Ability to work in a team environment, including inter-departmental teams and representing the organization on specific projects

Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations

Strict attention to detail

Ability to manage competing priorities in a fast paced environment

Adhere to department SOPs and a regulated environment

Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.

Keywords: Mindlance, Irvine , USA_Analyst, EDC Database Validation, Professions , Irvine, California