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| Job #03615 |
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| About our client |
| Our client is a leading provider of products and services for respiratory care. They have a number of marketed products and are well-known for their high level of quality. This is an excellent opportunity for the right person. |
| Position |
Location |
| Director of Data Management |
Colorado |
| Salary |
| Highly competitive package, commensurate with experience |
| Responsibilities |
1) Oversee and manage all aspects of data management day-to-day operations 2) Apply a high level of technical expertise to lead and develop the clinical analysts, data managers and clinical programming staff 3) Serve as a subject matter expert in supporting business development during capabilities presentations to prospective and current customers 4) Develop data management plans and identify/customize for new studies 5) Participate in reviewing protocols and develop proposals 6) Provide and maintain metrics to monitor efficiency and quality 7) Ensure timely processing and validation of study data 8) Develop, revise and train staff to SOPs to ensure integrity of data and reports while complying with 21 CRF Part 11 9) Create data management plans and act as a primary interface to customers on all matters of data collection, review, quality and transmission 10) Adhere to all company policies, procedures and business ethics codes and ensure that they are communicated and implemented within the team 11) Demonstrate success in matrix environment 12) Work closely with project managers, core team members and functional organization to drive the data management aspects of project delivery 13) Demonstrate ability to interact and cooperate with executive team and other functional areas to drive reporting and customer responsiveness 14) Recruit, direct, develop, coach and motivate staff |
| Requirements |
1) Bachelor's degree in Applied/Life Sciences or Biostatistics (Master's degree or equivalent is preferred) 2) Minimum 8 years of related experience in clinical data management for a pharmaceutical, biotech or CRO company 3) Experience in interacting with customers/sponsors 4) Extensive experience in and knowledge of ICH guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations 5) Experience in advanced SQL and SAS 6) Experience in respiratory/critical care a plus 7) Demonstrated success in a matrix environment |

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