Clinical Research Data Project Manager

Baptist Health South Florida•Miami, FL

2d•Remote

About The Position

BAPTIST HEALTH SOUTH FLORIDA INC. in Miami, FL seeks a Clinical Research Data Project Manager to be responsible for the planning and implementation of the data management portions of clinical research projects, including development and maintenance of comprehensive relational database. Responsible for ensuring the accuracy and integrity of the data, including data extraction, processing, storage, and analysis. Set up and maintain data management study files for inclusion in the Trial Master File, ensuring these are maintained in an audit ready state. Create and design queries of research databases for the extraction of data and performance of quality assurance activities, including clinical trial data review. Implement documentation and archival standards of data management deliverables including data management systems, databases, programs, and specifications. Develop data management plan, maintains data management plan throughout the lifecycle of study project and ensure plan is followed according to study design and requirements. Develop database clinical trial data specifications, including electronic case report form design, user requirements, edit rules/checks, query logic and data validations. Provide training to study staff for electronic data capture system and create user guidelines for data entry. Define, program, and validate all edit checks into study database for each project or clinical trial using Electronic Data Capture (EDC) software. Serve as the primary point of contact for all study data related inquiries and issues. Provide regular updates on study data collection efforts and progress with the development and creation of data management plans, case report forms and quality assurance activities. Review case report forms for completeness and consistency, query data inconsistencies and revise case report forms in compliance with standard operating procedures.

Requirements

Bachelor’s Degree (U.S. or foreign equivalent) in Biostatistics, Public Health, Computer Science, or a related field.
5 years of experience in same or similar occupation.
The 5 years of experience must include: (a) 3 years of prior data management & analysis, including SAS (or similar coding language or statistical programming tool); (b) 3 years of experience interacting with statisticians regarding sophisticated data analysis approaches to be implemented; (c) 5 years of experience using Microsoft toolset (Excel, Word, PowerPoint; (d) 3 years of experience in clinical research or healthcare-related research, fundamental database design including relational constructs, query design, database normalization, indexes, and constraints; (e) 5 years of experience managing multiple projects simultaneously which includes excellent planning, time management, communication, decision making, organization, and interpersonal skills.
Collaborative Institutional Training Initiative (CITI) Certifications in: (a) Biomedical Human Subjects Research; (b) Good Clinical Practice; (c) Conflicts of Interest; (d) Protocol Development & Execution: Beyond a Concept

Responsibilities

Planning and implementation of the data management portions of clinical research projects, including development and maintenance of comprehensive relational database.
Ensuring the accuracy and integrity of the data, including data extraction, processing, storage, and analysis.
Setting up and maintaining data management study files for inclusion in the Trial Master File, ensuring these are maintained in an audit ready state.
Creating and designing queries of research databases for the extraction of data and performance of quality assurance activities, including clinical trial data review.
Implementing documentation and archival standards of data management deliverables including data management systems, databases, programs, and specifications.
Developing data management plan, maintains data management plan throughout the lifecycle of study project and ensure plan is followed according to study design and requirements.
Developing database clinical trial data specifications, including electronic case report form design, user requirements, edit rules/checks, query logic and data validations.
Providing training to study staff for electronic data capture system and create user guidelines for data entry.
Defining, programing, and validating all edit checks into study database for each project or clinical trial using Electronic Data Capture (EDC) software.
Serving as the primary point of contact for all study data related inquiries and issues.
Providing regular updates on study data collection efforts and progress with the development and creation of data management plans, case report forms and quality assurance activities.
Reviewing case report forms for completeness and consistency, query data inconsistencies and revise case report forms in compliance with standard operating procedures.