Senior EDC Software Developer

Octagon Research Solutions, Inc., is a fast growing Development Partnering Organization (DPO), which acts as a virtual partner in supporting its Biopharmaceutical & Pharmaceutical clients throughout the entire clinical research, development and submissions process. Based in Wayne, PA, Octagon meets their client's unmet needs by integrating information technology and multidisciplinary services to create a complete solution. We offer unparalleled practical knowledge and industry expertise that spans the clinical research and development lifecycle.

Currently, we are experiencing significant growth in our Mountain View, CA and Wayne, PA locations and are conducting a nationwide search in efforts to expand our EDC Operations Team. Reporting directly to the Manager of Software Development, the Senior Software Developer will be responsible for the writing of detailed application configuration code and the construction of software modules that implement the specifications provided by the Clinical Solutions Consultant (CSC) for an EDC application and also the development of new features that will be added to the product platform (Fuse).

Ability and motivation to serve in the role as Team Lead for various commercial and internal product development projects.
Work closely with the CSC to ensure the developing specifications can reasonably be satisfied on the current version of the EDC platform – know the platform capabilities and limitations.
Work closely with the Project Manager and the CSC to ensure that customer requirements are clear, unambiguous and complete. Manage your SDLC assigned tasks for each customer per the project plan and provide weekly progress updates to Project Management
Become the subject matter expert (SME) on SDLC (discover, design and development phases) and in improving the lifecycle processes, templates and tools.
Since you are working in a regulated industry, the quality of your work must be high and in compliance with all applicable SOPs and WIs.
Both detail oriented (collaborate with the project team members to drive toward completeness and prevent things from falling through gaps) and also big picture oriented with the capability of chalk-talking thorough your ideas on how to complete projects more effectively and identify what tool automation might be useful.
Work closely with Quality Control to ensure the EDC project solution meets customer requirements and installation & performance qualifications

The successful candidate will have a combination of the following skills/experience:

5+ years of progressively deeper experience in developing web based software applications using the .NET framework (ASP.NET, C#, Visual Studio IDE, HTML, JavaScript, AJAX)
3+ years experience in developing applications using XML technologies
2+ year experience in authoring stored procedures and UDF in Transact-SQL on Microsoft SQL Server 2000/2005.
Competent written and oral communication skills and the ability to engage with staff and customers effectively.
Ability to work cooperatively with project manager to identifying work completion levels and work remaining.
Demonstrated ability to manage one’s own work and time based on the project plan, assigned tasks and milestones, and direct one’s own efforts effectively.
A solid understanding of HTML, databases, messaging services, enterprise application integration, and other Internet, security, and software technologies is a plus.
Knowledge of quality assurance processes in a FDA regulated software development environment is a plus.
BS/BA in SW Engineering or IT/MIS

Desirable:

Experience and knowledge of clinical trials, CRFs and clinical ops related processes.

Software implementation experience in regulated environments (e.g. FDA) in compliance with regulatory SOPs and WIs.

Octagon is an Equal Opportunity Employer with an outstanding corporate culture. We are an emerging growth company providing a business casual environment, strong benefits, competitive compensation and outstanding career advancement opportunities. The entrepreneurial setting, coupled with our financial stability, has made us an employer of choice, and one of the most sought after Life Sciences employers in the area. Please visit us at www.octagonresearch.com to learn more about how we are revolutionizing the drug development lifecycle.

To apply, please forward your resume to Laurie Koch, Recruitment Manager, Talent Acquisition at lkoch@octagonresearch.com.