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Manager of Clinical Systems
We are seeking a Manager of Clinical Systems to join our professional team in Pittsburgh, PA. As the selected candidate you must possess a unique blend of business and technical savvy.
Responsibilities:
- Manage all aspects of the development, translation, deployment, and quality control of study-specific DiaryPRO®, SitePRO®, and web implementations of our products.
- Responsible for creating, approving, and implementing departmental standard operating procedures and work instructions; ensuring all development practices and procedures meet the regulatory compliance standards and Good Clinical Practices.
- Monitor Standard Operating Procedure [SOP] compliance of internal and off-shore teams and vendors, and report any deviations to QA and facilitate corrective action
- Manage aspects of post-Gold Master change control validation for development, quality control, and deployment deliverables
- Act as a technical expert and resource for the development and quality control teams.
- Work in conjunction with team leads to plan, schedule, and appropriately scale resources to meet development, quality control, and implementation timeline deliverables for client projects.
- Communicate with internal and off-shore teams and vendors to ensure timely completion of tasks.
- Monitor training fulfillment and support training activities for the team.
- Drive continuous process and tool improvement initiatives.
- Define and drive quarterly goals for department as they relate to company business objectives and assign specific objectives to team members.
- Act as cross-functional team member for new product development and operations projects; monitor and participate in creating training plans and CSI development tools for new products.
- Develop metrics for group performance and deliver reports to management and Board of Directors communicating those metrics.
- Create and manage budget for both onshore and offshore teams.
- Perform other duties as assigned by management
Qualifications:
- BS degree in Computer Science, Masters preferred, or equivalent work experience
- Prior supervisory experience required
- Vendor management experience required
- Offshore development/testing management experience preferred
- Highly Organized
- Strong Problem Solving Skills
- Must be able to drive for results in a fast paced environment
Skills:
- Experience in managing Web-deployed software application development required.
- Experience designing and implementing software solutions on both Palm and Windows mobile devices strongly preferred.
- Strong project management skills required
- Strong competency of Microsoft Excel required
- Knowledge of SEI, CMM and other SW quality standards strongly preferred.
- Strong Communication skills – verbal, written, and presentation skills required.
- Software knowledge of C++, Cold Fusion, Microsoft SQL, and Microsoft .NET strongly preferred
- Foreign language skills a plus.
Travel Requirements:
- A maximum of one quarterly visit outside of the United States