Design Consultant, IRT Services Organization Name :
Health Sciences Global Business Unit
The Oracle Health Sciences Global Business Unit (HSGBU) is a specialized business unit focused solely on the software and service needs of the health sciences industry. By delivering software solutions aimed at adding value to Healthcare and life science organizations the HSGBU has the opportunity to be at the forefront of enabling better patient outcomes within the industry.
The HSGBU SaaS Consulting Services department works with our Life Science customers to implement HSGBU platform software solutions that enable them to deliver innovative therapies, devices diagnostics and optimized care processes to prevent and cure illness.
The HSGBU Consulting IRT Services department sits within the Oracle Health Sciences Global Business Unit and is responsible for delivering SaaS IRT projects to Cloud.
The Design Consultant is part of the global Interactive Response Technology (IRT) Professional Services team that will deliver quality IRT study trial design, development oversight, testing oversight, project management and consulting to our pharmaceutical, biotechnology, medical device, CRO, and academic/public health clients. The successful candidate will have responsibility for a variety of clinical trial functions at Oracle, including gathering and interpreting customer clinical trial requirements and translating them into design specifications.
To learn more about our suites, visit http://www.oracle.com/us/industries/life-sciences/037879.htm . Responsibilities:
The responsibilities of this individual include, but are not limited to, the following:
- Work as a high profile member of the project team to ensure excellent customer relationships are established throughout the study design, development, implementation and maintenance of the trial.
- Function as the design expert to advise internal and external customers regarding best practice for IRT design.
- Gather and interpret customer requirements and translate these into design specifications including study randomization schemas and drug supply methodology.
- Generate data export specifications to map data to customer requirements.
- Work with the study team to scope required effort and define timelines.
- Provide advice and implement design related changes throughout the trial life-cycle
- Actively contributes to the continuing development of the product function and improvement of the clinical design working practices
- Advise customers to ensure that the study trial design is configured in such a way that it meets the customer's goals and offers the full benefits of Oracle's IRT application.
- Follows and implements all SOPs and Work Instructions by applying Oracle's clinical and software development process and methodology.
- Provides some mentoring to junior staff and customer users.
Education and Experience:
- Knowledge of clinical studies and trial design required.
- Knowledge of clinical research industry and practices and ICH/GCP Regulations
- Knowledge and understanding of regulations associated with clinical trial data handling, including HIPAA and 21 CFR Part 11.
- Product, technology or industry expertise relevant to IRT is a plus.
- Demonstrated experience in gathering requirements, design, and specification development (including writing and reviewing technical documentation) is required.
- Able to review and interpret clinical trial documentation (e.g. protocols).
- Experience and demonstrated understanding of computer systems and software application implementation (web and/or customer server) including knowledge of software development life cycle.
- Ability to manage multiple tasks and project deliverables.
- Demonstrated success with customers during project assessment, planning, development, training and implementation.
- Proven track record of meeting project timeliness/deliverables and attention to detail, process, deadlines and quality results.
- Strong communication skills to deal with internal stakeholders, customers, and vendors.
- Excellent verbal and written communication, interpersonal, and presentation skills a must.
- Self motivated and keen ability to multi-task
- Ability to work as part of a team, yet work independently on complex problems.
- Knowledge of SQL, XML Web services, sFTP and SAS is an asset
- Operating Systems - Windows
- Bachelor's Master degree or equivalent experience.
- Minimum of 3 years life sciences industry experience and knowledge of clinical trial process (pharmaceutical, biotech, medical device companies, CRO's and academic & public health organizations).
- IRT experience preferred.
- Consulting experience.
- Logical approach to problem solving and excellent eye for detail.
- Excellent spoken and written English. Other languages are an asset.
25-30% travel Qualifications:
An experienced consulting professional who has an understanding of solutions, business processes, or technology designs within a product/technology family.
Operates independently to provide quality work products to an engagement. Performs varied and complex duties and tasks that need independent judgment, in order to implement Oracle products and technology to meet customer needs. Applies Oracle methodology, company procedures, and leading practices. Demonstrates expertise to deliver functional and technical solutions on moderately complex customer engagements. May act as the team lead on projects. Effectively consults with management of customer organizations. Participates in business development activities.
5-7 years of experience relevant to this position including 2 years consulting experience preferred. Undergraduate degree or equivalent experience. Product or technical expertise relevant to practice focus. Ability to communicate effectively. Ability to build rapport with team members and clients. Ability to travel as needed.Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans status or any other characteristic protected by law.