Sr Analyst, EDC Database Validation
Website TalentBurst, Inc.
Company : TalentBurst, Inc.
Country: United States
Location : Irvine, California
Post: Fri, 10 Sep 2021 17:02:30 GMT
Expires: Sun, 10 Oct 2021 23:59:59 GMT
Apply Job : Apply Online
—————————— Job Description ——————————
Position: Sr Analyst, EDC Database Validation, Req#:
Location: Irvine, CA, Remote
Duration: 12+ Months Contract
* Prefer a local candidate but am open to Remote anywhere in the U.S.
* If local candidates, they will be required to work onsite.
* The intention is a contract to hire – location does not affect this.
* Medidata Rave experience is a must
Education and Experience:
* Bachelor’s Degree in (e.g., computer science, or any field related to clinical research, data management, software programming) Required and 4 years of experience programming or validation experience Required
* Experience with EDC (Electronic Data Capture) systems required (e.g., Medidata RAVE) Required
* Programming experience in the pharmaceutical/medical device industry setting Preferred
* Proven expertise in Microsoft Office Suite
* Basic project management skills
* Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills
* Excellent problem-solving and critical thinking skills
* Full knowledge and understanding of policies, procedures, and guidelines relevant to EDC (Electronic Data Capture) validation
* Full knowledge of processes and procedures in clinical data management
* Full knowledge of relational databases, systems, and programming languages
* Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on 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 Key Responsibilities:
* Develop test scripts, review tests scripts with data managers, 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
* Provide insights, identify validation issues, and partner with stakeholders (e.g., programmers, data managers, and data coordinators) to address and resolve issues
* Create validation summaries and reports and provide insights into the validation to ensure project deliverables and timelines are met in collaboration with the Internal team, Data Management, Programmers, Clinical Affairs
* Create and update functional specifications for the validation tool (e.g., SAS program) using specialized technical knowledge
* Author and execute validation scripts for clinical reports
* Perform study database design and build programming activities
* Assist in creating clinical listings and reports for data managers
* Other incidental duties #LI-FRESH
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