Senior EDC Clinical Solutions Consultant

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 successfully 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 area and are conducting a nationwide search in efforts to expand our EDC Operations Team. Reporting directly to the Vice President of EDC Operations, the Sr. Clinical Solutions Consultant will be responsible for the following:

Guide the customer during the initial requirements process so that the EDC specification takes advantage of Octagon EDC platform capabilities in achieving the functionality needed by the customer
Work with customer and Octagon Implementation Services team to transfer a clear understanding of the requirements (including CRF design, edit checks, clinical workflow), anticipate customer needs, and remove ambiguity in the requirements process
Complete and baseline the Octagon specification documents (UI wireframes, edit check and workflow specifications, etc.)
Work with Quality Control to clarify customer requirements as they use the specification to develop the system test plan and procedures
Work with Project Management in the evaluation of customer change request and the assess the impact and best approach to a solution
Work with customers to define the data transfer plan, data integration points and reporting/listing requirements
Assist in defining and enforcing Octagon data collection and data management standards and comply with all regulatory requirements

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

5+ years experience with clinical trials and the associated clin-ops workflow in bio-pharm
Solid understanding of clinical trial protocols, CRF layout, clinical data collection and management issues
Travel required up to 25%
Strong written, oral & presentation skills
Self directed and detail oriented

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.