Data Manager

Premier Research Group Limited - Waltham, MA (30+ days ago)


Position Summary:
Assists in preparing data management plan, processing of discrepancies and query generation. Reviews CRF's, data listings, and database to ensure that all captured data follow the rules outlined by the protocol and data management plan (DMP).

You'll be Accountable for:
Assisting in preparing clean databases, including processing of discrepancies and queries
Preparation of the DMP
Reviewing CRFs, data listings, and database to ensure that all captured data follow the rules outlined by the protocol and data management plan
Generating paper and electronic queries to appropriate internal or external personnel (investigational sites, vendors, Clinical Research Associates (CRAs), client representatives) to resolve problematic data identified during every aspect of the data management process
Reviewing responses to queries for appropriateness, resolving any discrepancies and modifying the database accordingly
Developing a standard set of test data for use in testing data entry screens, data listing presentation, and programmed logical edit checks, as required
Preparing documentation noting the testing changes and performing follow-up testing to validate that the changes have been made, as required

You'll Need This to be Considered:
Ability to act as a data management core team lead for at least one project
Understanding and experience in Windows (98 or above) and at least one Database Management System (e.g., SAS, Oracle, Clintrials, Oracle Clinical, RAVE etc.)
Attentive to details and able to independently resolve a variety of issues without close supervision
Working knowledge of medical terminology and experience with clinical research desired
Excellent oral and written communication skills
Excellent customer relation skills
Capable of multi-task orientation
Ability to perform overnight business travel, up to 10%
Minimum of a Bachelor's Degree, preferably in science, engineering, or math, or an RN, RPh, or LPN certification preferred
Minimum of two years data management experience