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Proj Manager, Data Management

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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.
 
 
Benefits of Working in ICON
 
Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package.  This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.
 
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.   
 
What’s Next?
 
Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.
 
ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.
 

 

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