Clinical Data Manager

• 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.

Requirements:

• 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 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.