FHI 360 is a global organization that mobilizes research, resources and relationships so people everywhere have access to the opportunities they need to lead full and healthy lives. With collaborations in over 60 countries, we work directly with local leaders to advance social and economic equity, improve health and well-being, respond to humanitarian crises and strengthen community resilience. We share data-driven insights and scalable tools that expand access and equity so communities can effectively address complex challenges, respond to shocks and achieve thriving futures.

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Job Summary

Directs the design, documentation, testing and implementation of data collection and database systems for collecting and storing study data for multiple, complex clinical studies concurrently. Provides input for protocol focused on data management issues. Coordinates design of case report forms to meet study objectives. Develops data management and data cleaning plans. Reviews and analyzes data discrepancies to identify and report data and trends. Manages data management issues for clinical studies providing on-going support and routine reports to the study team. May also be responsible for projects that have been contracted with contract research organizations, as well as internal projects. Works on complex studies consisting of 2+ countries, each possibly with multiple sites, where data entry occurs at regional data entry centers external to FHI 360. 

Develops systems for organizing data to analyze, identify and report data and trends. Manages data management issues by reviewing protocols for cross-project consistency and identifying standard case report form modules to meet objectives. Develops study budgets. Provides early strategic input into protocol design focused on data management issues. Mentors Data Management personnel to ensure the efficient operation of their function. Conducts data management workshops, training and site assessments.

Accountabilities:

• Manage all operational aspects of clinical trials in compliance with GCP regulations, HS policy and Client Company policy.
• Review and manage project budgets, timelines and resources across Client programs and studies.
• Ensure timeliness of deliverable s for each phase of the study from study start-up through production and close-out activities.
• Interact with various Data Management and other functional area colleagues, including, but not limited to: Biostatistics and Programming, Clinical, Project Management, Safety, Medical Coding, site personnel.  
• Ensure Clinical Data Management staff maintains all relevant documentation associated with each assigned Protocol.
• Identify and work collaboratively and cross-functionally to implement process improvement measures within data management on both departmental and project level.  
• Coordinate with Clinical Data Management Staff, Client, and Study Team to identify issues/trends for discussion.
• Participate in study/project team meetings as primary facilitator of timelines, providing updates on study status to the cross functional team.  

Problem Solving & Impact:

• Problems are complex and require analysis of situations and data with evaluation of various factors.  
• Exercises judgment within broadly defined practices and policies to select methods and techniques to obtain results.
• Decisions and actions may cause delays and affect a business unit or functional area within a department.

Education:

• Bachelor’s Degree or International Equivalent in Computer Science, Life Science, Health Science, Information Management or Related Field.
• Project Management (PM) Certification preferred.

Experience:  

• Typically requires 8+ years of data management and systems experience.  
• Proficiency in Excel software and other database technologies required.  
• Prior work experience in a non- governmental organization (NGO).

Supervision Given/Received:  

• Coordinates activities in the development of software tools, surveys, visit trackers and mobile data collection instruments for a study.
• Ensures issues with studies or other projects are resolved in a timely fashion.
• Participants in developing procedures, budgets, training and resources with management to achieve strategic goals.

Technology to be Used:  

• Personal Computer/Laptop, Microsoft applications (i.e., Office 365, SharePoint, Skype/Zoom/Teams), cell phone/mobile technology, and standard office equipment.

Typical Physical Demands:  

• Typical office environment.
• Ability to spend long hours looking at computer screen and doing repetitive work on a keyboard.
• Ability to sit or stand for extended periods of time.
• Ability to lift/move up to 5 lbs.

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