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Form of workJob Description
Under limited supervision, but following established policies and procedures, the Data Manager is responsible for collaborating with various departments on the design, documentation, testing and implementation of clinical studies. Develops systems for organizing data needed for analysis;
identifies and reports trends related to clinical study data and oversees query management. Prepares a variety of reports related to clinical trials status for internal teams and sponsors. Identifies, evaluates and resolves issues regarding content of reports. Assists and reviews work of Clinical Data Specialists as needed. Responds to questions and/or provides information upon request from clients, vendors, sites and internal staff.
RESPONSIBILITIES:
Develops and/or reviews the DMP and appendices for each assigned clinical study. Adheres to the specifications set forth in the DMP; Produces study documentation, including but not limited to maintaining decision logs, database change order forms, and memos
Manages the design and development of eCRFs (Case Report Forms) for assigned clinical studies per the CDISC standards
Designs and builds clinical study databases. Conducts the review and user acceptance testing (UAT) of database designs for accuracy. Assists with conducting the Database Validation performed on each database for each study; Creates edit check specifications, programs edit checks and conducts UAT of edit checks; Conducts EDC training and user account management
Performs and maintains medical coding of applicable clinical data
Performs data reviews and reconciliations (SAEs, Concomitant Meds etc.) in accordance with the DMP and generates manual queries for discrepant data for resolution/clarification
Generates regular metrics reports and provides updates on data cleaning status. Prepares and sends ad-hoc reports to the internal team and/or to the Sponsors as needed or requested
Assists in final close out of a study, including, but not limited to Quality Control reviews and data archiving
Utilizes tact and experience-based knowledge to resolve problems (clients or staff), explaining specific policies while representing the Company in a professional manner and maintaining positive client relations
Ensure adherence to company and/or study specific SOPs, ICH Good Clinical Practices and FDA regulations
Performs other clinical data management and/or administrative duties as assigned by the Assistant Director, Clinical Data Management.
Experience/Skills/Knowledge:
Minimum 3-5 years of experience in the field of Clinical Data Management
Minimum 3-5 years of experience with a 21 CFR Part 11 compliant Clinical Data Management System (CDMS); Medidata Rave, Oracle InForm, Merge, Medrio, or other reputable EDC systems.
Experience in the field of database design or eCRF development
Demonstrates knowledge and experience with using CDISC standards as they pertain to eCRF development, database design and implementation
Demonstrates working knowledge of medical/scientific terminology; knowledge of FDA regulations and ICH GCP guidelines is required ? Travel may be required
