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.
Escalate any potential or actual issues to supervisor, project team, and/or Client Company in a timely manner, and follow issues through to resolution.
Provide written project status reports to Client Company and/or HS Data Management supervisor and verbally present as necessary at Client Company meetings.
Delegate or assist with delegating daily tasks for all protocol(s) to Lead Clinical Data Managers, Clinical Data Managers, and/or Data Entry staff.
Contribute to the development and/or revision of Clinical Data Management SOPs and related documentation.
Assist in establishing metrics for project progress, performance, and cost. Assist in evaluating project performance to these standards.
Monitor performance goals and objectives to ensure quality in the processing of data generated from clinical trials.
Serve as primary point of contact for all Client Company project timeline related communication.
Assist supervisor as needed with resource planning/forecasting.
Monitor and work to maintain/improve Client Company satisfaction by ensuring high quality service, communication, and management of clinical data.
Escalate potential/actual issues regarding, IT connectivity, Sponsor relations, staffing needs that could potentially impact timelines and deliverable s to HS management.
Maintain awareness of team membersโ PTO requests, ensuring all Sponsor deliverable s will be maintained.
Contribute to Annual Employee Performance Evaluations as needed, upon request of management.
Establish appropriate project tracking using computer assisted programs and ensure timely entry of project information.
Evaluate and manage project budget against project milestones to ensure project profitability.
Take corrective measures where necessary to keep project in line with budget and profit expectations.
Conduct internal and external project team meetings as needed.
Assist supervisor with interview and selection process of new staff.
Support documentation of initial and ongoing staff training as required by both the Client Company.
Work closely with the CDM Proposals, Clinical Operations, Medical Affairs, Strategic Alliances, Strategic Development, Strategic Operations and Information Service Departments to perform appropriate client, indication and therapeutic area research to support the proposal development and required study change orders.
Involving the in the design process to ensure that solutions can be implemented.
Working with data management to validate designed functionality.
Applied Knowledge & Skills:
- Comprehensive knowledge of concepts, procedures, and practices with data management.
- Excellent oral and written communication skills.
- Excellent quantitative and analytical skills.
- Strong critical thinking and problem solving skills.
- Ability to analyze and interpret data, identify errors and prepare reports.
- Ability to influence, motivate and collaborate with others.
- Ability to successfully multi-task, prioritize, manage multiple projects.
- Ability to lead initiatives to evaluate new technologies and resources.
- Articulate, professional and able to communicate in a clear, positive manner with clients and staff.
- Must be able to read, write and speak fluent English.
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.