ERT - Philadelphia is hiring a Solutions Design Analyst! The SDA is responsible for delivering the highest quality BI solutions design consultation to our pharmaceutical/biotechnology industry clients. The Solutions Design Analyst will be aligned with one or more project teams as well as interface with clients, eClinical vendors and ERT solutions delivery leadership. The Solutions Design Analyst will ensure that clinical protocols are mapped to BI solutions efficiently, accurately, and within project scope.
ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that our customers can move ahead with confidence. With more than 45 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so it can adapt without compromising standards.
Powered by the company’s EXPERT® technology platform, ERT’s solutions enhance trial oversight, enable site optimization, increase patient engagement, and measure the efficacy of new clinical treatments while ensuring patient safety. Over the past four years, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, Biotechs, and CROs have relied on ERT solutions in 9,500+ studies spanning three million patients to date. By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly – and with confidence. For more information, go to ert.com or follow us on LinkedIn, Twitter, and Facebook.
Essential Duties and Responsibilities:
- Solutions Design
- Coordinate the overall Solutions Design Process ensuring that clinical protocols are appropriately mapped to BI solutions efficiently, accurately and within project scope
- Develop and communicate design best practices for BI solutions
- Gather and document sponsor and/or eClinical vendor requirements and specify design components to support those requirements
- Create and maintain specifications for study-specific implementations of BI products and services using a Documentation Management System
- Ensure consistency between trial data capture, data delivery and database structures to meet client requirements
- Responsible for the overall management of the Design Process including communication of design requirements internally and externally with the Customer and eClinical Vendors. This includes participation in internal and external design milestone meetings
- Track Design related milestones and timelines
- Support Solutions Validation/Quality Control testing by addressing any defects associated with the design in a timely manner
- Collaborate with other departments to investigate study issues found beyond the start-up phase of the study
- Collaborates with DM, Solution Design Analysts and eClinical vendors to ensure that the software solution captures the necessary data points for data extraction, visualization and real-time integration
- Assist in project scoping and change control processes including revision management
- Product Development
- Provide feedback to Product Development group on new product functionality
- Process Development
- Provide input to interdepartmental process improvement initiatives
- Track time for billable study related and non billable tasks in a timely manner
- Track SDA milestone start and completion dates using the ERT project scheduling tool
- Complete activities in the Training Management System in a timely manner
- Perform other duties as directed by Solutions Design Management
The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. This job description and any attachments do not constitute or represent a contract.
Qualifications and Skills Needed:
- BS, BA or equivalent (Degree in science/healthcare-related field a plus)
- Minimum of 3 years of experience in the execution of clinical trials or equivalent
- Ability to understand and interpret clinical trial documentation such as protocols, clinical data models and other eClinical data collection instruments
- Demonstrated experience in interpretation of client requirements to prepare and document design specifications
- Proven experience in client relations and interactions with clients at all levels
- Familiarity with FDA regulatory processes, clinical research processes
- Self directed - comfortable working in a fast-paced environment
- Ability to manage multiple project tasks and deliverables
- Proven problem-solving skills and attention to detail
- Excellent presentation, communication (written and oral) and negotiation skills
- Ability to travel up to 25%
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.