USA_Analyst, EDC Database Validation
Company: Mindlance
Location: Irvine
Posted on: August 7, 2022
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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
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