Data Analyst 3

Description:
REMOTE POSITION

The Data Manager oversees the studies to drive innovative database building, data collection, tracking and review solutions from complex, diverse sources to ensure timely delivery of high-quality data in a regulated and changing global clinical trial environment.
The role involves interfacing with statisticians, clinical affairs representatives, and external partners and vendors to design, configure, and test the clinical database systems. The CDM will also be involved in troubleshooting any issues on behalf of the end users and maintaining data standards.

The position will report to the Director of Data Management within Medical, Biostatistical and Design Quality (MBDQ).

Duties & Responsibilities:
Conduct Study Preparation Meeting (SPM)
Create and Validate Data Management Report Specifications
Work with Database Engineer to create the EDC database specification
Upload preliminary testing data into database
Conduct User Acceptance Testing (UAT)
Create CRF Completion Guidelines
Create and sign-off on the Data Management Plan (DMP)
Drive the use of data standards (i.e., CDISC)
Participate in Study Element Team Meetings
Train end users on eDC system
Grant User Access for eDC system
Adds and/or updates external users' ids in GAMA
Contributes to departmental process improvement initiatives

Required Knowledge/Skills, Education, and Experience:

Master's degree in a science related field
At least three (5) years data management and/or related work experience in a medical device or pharmaceutical industry/company
Working knowledge within areas of Good Clinical Practices, Good Clinical Data Management Practices, Design and Conduct of Clinical Trials/Studies, and related regulatory requirements and terminology
Experience working within a Clinical EDC system (e.g., OpenClincia, Medrio, Medidata Rave)
Exposure to clinical data coding classification systems, e.g., MedDRA, LOINC, WHO-Drug, Data Standardization (CDISC STDM &/or ADAM), Meta-Data Repository
Programming knowledge Python or R is desired
Strong interpersonal, organizational, and communication skills
Excellent attention to detail and problem-solving skills
Ability to work effectively work in a team setting