Lead Data Manager

Title: Lead Data Manager

Position Summary

• Support Data Management Project Leads in the execution, delivery, and achievement of project milestones on assigned studies
• Provide independent project leadership and serve as a resource for projects, deliverables, an improvement initiatives in the Data Management department.
• Coordinate data management resources and activities for assigned studies to ensure that study deliverables are achieved on time and to the highest quality.

Job Functions/Responsibilities

• Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance. As a member of staff, the employee is expected to embrace and contribute to our culture of processimprovement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Travel (approximately 2%) domestic and/or international.
• Support, direct, or perform the development and quality reviews of key study documents such as the Case Report Form (electronic or paper), CRF Completion Guidelines, Data Management Plan, Data Validation Specifications, Data Management Report, Study Specific Procedures and Forms, and other documents, as required.
• Support, direct, or perform the development, validation, and User Acceptance Testing of the clinical data management system database and associated edit checks.
• Support, direct, or perform all Data Management data processing, data reconciliation, query generation and resolution, cleaning, medical coding, quality review tasks, database closellock, and relevant archiving of study materials.
• Resolve issues for assigned projects related to quality, project delivery, compliance, and/or client relationships and satisfaction.
• Coordinate the activities of Data Management project team members to ensure timely and high quality deliverables.
• In collaboration with the Data Management Project Lead and/or department manager/designee, continually evaluate project resource requirements to ensure project objectives are maintained.
• Provide regular status reports to the Data Management Project Lead, department manager/designee, or other senior management, as required, communicate potential risk factors in a timely and appropriate manner, and actively partiCipate in study lessons learned meetings.
• For each project, maintain all required Data Management documentation in a manner consistent with applicable SOPs, and ensure project files, both paper and electronic, are maintained in an audit-ready state at all times.
• Provide project team training in Data Management systems and processes.
• Serve as a backup project lead for the Data Management Project Lead on assigned projects, as required.
• Represent the Data Management department for internal and external meetings and audits.
• Ensure continual compliance with all training requirements and actively pursue opportunities for professional development.
• Serve as a mentor for other staff in the Data Management group, and provide input to the performance appraisal process as requested.
• Participation on special projects, as required.
• Undertake other reasonably related duties as may be assigned from time to time.
• Supervision:

  Mentor/train other staff members as required.

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Prior relevant clinical data management experience.
• Prior experience successfully leading clinical data management project teams is desirable.
• Ability to coordinate data management study management.
• Demonstrated experience with at least one clinical data management system (e.g., Oracle Clinical, Medrio, InForm, OC-RDC, Rave) and knowledge of database concepts.
• Knowledge of applicable regulatory requirements as they relate to clinical data management practices.
• Ability to successfully manage multiple tasks and timelines and perform assigned tasks with minimal supervision.
• Ability to liaise successfully with project teams, including strong written and verbal communication skills.
• Bachelor's degree or local equivalent in medicine, science, or other relevant discipline.