Clinical Research Data Project Manager

Baptist Health is the region's largest not-for-profit healthcare organization, with 12 hospitals, over 29,000 employees, 4,500 physicians and 200 outpatient centers, urgent care facilities and physician practices across Miami-Dade, Monroe, Broward and Palm Beach counties. With internationally renowned centers of excellence in cancer, cardiovascular care, orthopedics and sports medicine, and neurosciences, Baptist Health is supported by philanthropy and driven by its faith-based mission of medical excellence. For 25 years, we've been named one of Fortune's 100 Best Companies to Work For, and in the 2024-2025 U.S. News \& World Report Best Hospital Rankings, Baptist Health was the most awarded healthcare system in South Florida, earning 45 high-performing honors.

What truly sets us apart is our people. At Baptist Health, we create personal connections with our colleagues that go beyond the workplace, and we form meaningful relationships with patients and their families that extend beyond delivering care. Many of us have walked in our patients' shoes ourselves and that shared experience fuels out commitment to compassion and quality. Our culture is rooted in purpose, and every team member plays a part in making a positive impact – because when it comes to caring for people, we're all in.

Description

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.

Qualifications

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

Travel: up to 5% (domestic travel)

Employer requires pre-employment physical, drug screen and background check (including a criminal background check).

Remote employment may be permitted with prior authorization of the employer

EOE, including disability/vets