Systems Quality Manager, Clinical Programming

About the Position:

Manage the quality aspects relating to the usage, design, development, validation, implementation, maintenance and support of electronic systems, programs, scripts and tools for clinical trial data capture (e.g., EDC Oracle Inform, IVRS, ePRO), data integration (e.g. ETL Informatica PowerCenter, SOA, PL/SQL. Oracle, Clinical Data Repository) and reporting/delivery (Business Objects, Spotfire, Sharepoint, Infopath, SDTM), Support the validation of electronic systems and programs as implemented internally or through external vendors according to current regulatory requirements. Implement, contribute to, manage and review the quality processes, workflows, programming standards, best practices and conventions. Manage Clinical Programming activities and personnel in support of the Clinical Trial Research and Development Lifecycle. The position is responsible for:

* Improving and maintaining consistency of Quality Deliverables.
* Leading the quality documentation effort within the team.
* Execution of the clinical programming operations against project timelines, and any other priorities.
* Collaboration with management within and outside the organization.
The employee must conduct their work activities in compliance with all relevant regulations, ICH, PhRMA, and CFR guidelines as well as all Company policies, and procedures. Allergan policies include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives. Qualifications

* 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.
* Technical abilities and skills in the Software Development Life Cycle, 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).
* Competencies and skills in the following: cross functional relationships, communication, execution/results/process improvement, customer satisfaction, people and talent management, strategic decision making, facilitating change, organization & industry awareness, influencing & team leadership, results orientation, ability to meet challenging milestones, ability to problem solve independently & with others
* Ability to travel 15%

To find out more about Real Staffing please visit www.realstaffing.com