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 Services & Consulting department works with our Life Science customers to implement HSGBU software solution that enables them to deliver innovative therapies, devices diagnostics and optimized care processes to prevent and cure illness.

The HSGBU Services & Consulting department sits within the Oracle Health Sciences Global Business Unit and is responsible for delivering projects to Cloud.

The Design Consultant is part of the Services team that will deliver quality study trial design within Clinical One (C1) and consulting to our pharmaceutical, biotechnology, medical device, CRO, and academic/public health customers. 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 working study within our C1 platform.

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 Randomization and Trial Supply Management (RTSM) and Data Capture (DC) design.
• Gather and interpret customer requirements and translate these into design including study randomization schemas and drug supply methodology, and data capture.
• 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 as needed
• 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 C1 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.

 

Requirements: 

• 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 RTSM is a plus.
• Product, technology or industry expertise relevant to Electronic Data Capture (EDC) is a plus.
• 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.
• Operating Systems -  Windows

 

Education and Experience:

• 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).
• RTSM and EDC experience preferred.
• Consulting experience including requirement gathering, design and specification development.
• Logical approach to problem solving and excellent eye for detail.
• Excellent spoken and written Japanese.
• Interacting with global members in English (conversational/business level)

 

As a member of the Consulting organization, you are responsible for ensuring that a quality, integrated software solution is delivered in a timely manner, at budget, and to our client*s satisfaction. This involves working closely with the client to understand and manage their expectations, as well as working closely with Oracle and third-party vendors to ensure delivery.

Creates and manages an overall project plan (including budget, structure, schedule, and staffing needs) for one or more Oracle engagements. Monitors and reports progress/changes against the plan. Drives implementation by providing motivation and direction.

Job duties are varied and complex, needing independent judgment. May have project lead role. A BS or BA in related fields. 5-7 year overall experience in functional or technical role. Two years experience in multi-dimensional issue resolution.