Sr. Clinical Data Analyst

The Sr. Clinical Data Analyst will assigned to new study builds/development from a project management perspective and technical aspects working with an external vendor. If they’re doing support they need to be self-motivated to identify changes and go into change cycle projects – getting documentation filled out, gathering approvals to make changes, writing test scripts, and working with data managers for final approvals. Reasons for the change cycle projects could be new edit checks are needed, not functioning correctly, or didn’t think about a specific function in the initial build etc. This person will be working with Medidata Rave as a platform that all clinical studies are developed in for all products to be released in market. For example, a study will be developed for a new product that needs to be launched in the market. The FDA requires the company to collect data and prove the product is worthy to go out to the public. This person will develop the study to capture the data and prove it’s valid to go forward.

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8+ years of experience (balance of someone who can adapt) in Medidata Rave Study Development, programming and documentation
SPECIFICALLY:
Go in and build screens
Build edit checks
Screen Design
Project management skills – go and get the work – management of external vendors that does development – change request (programming) – if the resources are internally – and not a high volume of change management, will do development internally
Ability to work with an external vendor and manage outsourced build process (12 week activity per each study)
Bachelor’s degree (Management information systems (MIS) or related field preferred)

What we DO NOT want:
A Clinical Data Manager
A candidate that only does data entry or query resolution

Batch uploader module
Coder module exp
Medidata study builder certified
Custom Function Development
OneCTMS

Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.