Specialist, Prin Medical Data - 101036 - Arden Hills, MN - 0300 Posted Date: August 22, 2013

Job Description

Prin Data Manager

Purpose Statement:

Medical Data Specialists are responsible for ensuring the quality and integrity of clinical data via the creation of tools such as data collection instruments, data management plans, database specifications, and edit checks, as well as the review of clinical data for completeness, accuracy, and consistency. They may also manage adverse event reporting as well as overseeing event and complaint processing in accordance with study specific operational plans. Medical Data Specialists achieve this through collaboration with clinical colleagues (e.g., Project Management, Trial Operations, Site Operations, Clinical IS, Medical Safety, Biostatistics, and Quality) and other cross functional team members (e.g., Legal and Regulatory).
Key Responsibilities:

Review clinical data for completeness, accuracy and consistency in accordance with the investigational plan.
Provide subject matter expertise to project team members during all phases of project life cycle.
Provides accurate and timely clinical data to internal and external customers upon request.
Develop, test, and maintain data management systems.
Provide subject matter expertise prior, during and post internal and external audits and inspections.
Assess type/level of processing to be done for adverse events.
Manage adverse event processing including report review, safety query management and expedited reporting.
Ensure adjudication and reconciliation of safety events are completed prior to data snapshots (if applicable).

Quality System Requirements:
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Experience Required

Qualifications:· Bachelor?s degree, Master?s preferred· 8+ years data management experience required· Safety experience preferred· EDC experience· Experience with clinical event committees· Strong organizational skills The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. Please contact your local EH&S department for more information on physical requirements.