CDISC Data Strategies 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 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.
We are seeking candidates with the following experiences:
- Team oriented, yet able to work independently
- Good knowledge of CDISC SDTM
- Working knowledge of ODM, ADaM and other CDISC/HL7 standards
- Strong Biopharmaceutical & Pharmaceutical references
- Regulatory Submissions knowledge, especially on the data submissions requirements
- In-depth knowledge of Clinical Data Management, including industry tools
- Highly refined consulting skills
- Public training experience
- Experience with Clinical Data Management and Analysis tools, including those used internally at Octagon, as well as other tools used in industry
Reporting directly to the Senior Director of Clinical Data Strategies, the Consultant's primary responsibilities will include the following:
- Lead or collaborate on client consulting projects dealing with the assessment, design and/or implementation of CDISC data standards. These projects might include, for example:
- Assessment and gap analysis
- A roadmap to define the strategic vision
- Conceptual and functional design for processes/systems
- Time and resources estimates
- Definition of a standards governance framework
- Inventory of standards metadata required in a metadata repository
- Give CDISC presentations both internally as well as within the industry, on CDISC and CDISC related topics. In addition, participation on a CDISC standards team is expected
- High level of communication skills and will have significant interaction with clients at various levels within a project. A Senior Consultant will represent Octagon on presentations, training events and client projects. Also, a Senior Consultant must be able to work in flexible work environments, working at the Octagon office, a home-based office or an onsite client office location
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.
