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US: Systems Development Manager

Date: _08-Oct-2012_
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Systems Development Manager

* Management and oversight of a clinical programming project team and external vendors. * Execution of the clinical programming activities against project timelines, and any other priorities. * Defining and implementing project deliverables. * Defining, planning, coordinating, tracking and communicating the status of development projects. * Collaboration with management within and outside the organization. * Ensuring quality of delivered developments. * Reviewing deliverable quality (peer review), assessment of risk, participating in change control processes.

* Degree or equivalent experience in Computer Science, Life Science or related field: BS/BA degree with 9 years experience, or MS degree with 7 years experience, or PhD degree with 4 years experience. * Minimum 4 years experience in a leadership role within a clinical programming organization, preferably within medium-large pharma or CRO. * Knowledge and understanding of Regulatory Guidelines for the use of computer systems in clinical studies. * Knowledge of clinical Data Management and Clinical Programming methodologies as well as current and emerging global industry standards. * Working knowledge of global standards related to clinical study data management activities (CRF design, data standards (CDISC; ODM, SDTM), database design, coding and coding dictionaries, etc.). * Ability to effectively interact with, and influence, others. * Expert technical abilities, experience and skills in all areas of the Software Development Life Cycle. * Strong relational database modeling, design and implementation experience. * Some experience with Service Oriented Architecture, Software as a Service and Web Services. * Computer Systems Validation experience and knowledge of Powercenter, UNIX, and Oracle are considered a plus. * Technical writing skills and experience. * Analytical, problem solving and technical skills. * Planning, organizational, and project management skills. * Negotiation skills. * Conflict management skills. * Attention to detail with high quality outputs. * Computer skills (MS Office; word processing, spreadsheets, graphics, PowerPoint). *

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Developer FYI Center