Data Management Project Leader- Any US location

• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Travel (approximately 5%) domestic and/or international.
• Coordinate the activities of Data Management project team members across all regions to ensure timely and high-quality deliverables.
• In collaboration with the department manager, continually evaluate project resource requirements to ensure project objectives are maintained.
• Direct, lead, 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.
• Direct, lead, or perform the development, validation, and User Acceptance Testing of the clinical data management system database and associated edit checks.
• Direct, lead, or perform all Data Management data processing, data reconciliation, query generation and resolution, cleaning, medical coding, quality review tasks, database close/lock, and relevant archiving of study materials.
• Resolve issues for assigned projects related to quality, project delivery, compliance, and/or client relationships and satisfaction.
• Provide regular status reports to the project manager, department manager, 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.
• Represent the Data Management and SAS Programming department for internal and external meetings, presentations, and audits.
• Ensure continual compliance with all training requirements and actively pursue opportunities for professional development.
• Participation in Business Development activities, including proposal development, providing input to costing, and attending bid defense meetings, as required.
• Serve as a mentor for other staff in the Data Management group, and provide input to the performance appraisal process as requested.
• Provide leadership or participation on special projects, as required.
• Undertake other reasonably related duties as may be assigned from time to time.

Role Requirements / Skills / Experience Required

• Bachelor's degree or local equivalent in medicine, science, business or other relevant discipline.
• A minimum of three years appropriate data management experience.
• Ability to coordinate data management study management.
• Demonstrated experience with at least one clinical data management system is required (e.g., Oracle Clinical), and experience with at least one Electronic Data Capture (EDC) platform is desirable (e.g., Medrio, InForm, OC-RDC, Rave).
• Knowledge of applicable regulatory requirements as they relate to clinical data management practices.
• Knowledge of relevant CDISC standards, such as CDASH and SDTM, is preferred.
• Prior experience with successfully leading clinical data management project team is strongly preferred.
• Ability to liaise successfully with project teams and sponsors, including excellent written and verbal communication skills.
• Due to the nature of this position it may be required for the employee to travel.  Therefore, dependent on the employee’s location, the employee may be required to possess a valid Drivers license.