Data Management Project Manager - home based anywhere in Europe
About the role
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Data Management Project Management – Early Phase – home based anywhere in Europe
· To provide project leadership and serve as a resource for projects, deliverables , and improvement initiatives in the Data Management department
· Coordinate the data management resources and activities for assigned studies to ensure that study deliverables are achieved on time and to the highest quality.
· Ensure all projects are conducted in accordance with Good Clinical Practices (GCP),applicable SOPs, and client requirements
· In collaboration with the department manager, continually evaluate project resource requirements to ensure project objectives are maintained.
· 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.
Requirements
· Prior relevant data management experience.
· Ability to coordinate data management study management.
· Demonstrated experience with at least one clinical data management system is required e.g., Rave, Medrio; lnForm).
· Knowledge of applicable regulatory requirements as they relate to clinical data management practices.
· Knowledge of relevant CDISC standards, such as CDAS H 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 writtenand verbal communication skills.
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