Opportunities
Oracle Clinical Study Designer
Department: Corporate
Reports to: Director, Clinical Technology
Overview: This person will design and create Oracle Clinical studies in conjunction with the Oracle Clinical developers, clinical data coordinators, and study project team leaders. This includes leveraging pre-existing GLib data objects, creation of new objects, creation of validation documents, and delineation of procedure requirements.
Responsibilities:
- Design, create, and validate new studies in Oracle Clinical; this includes data object configuration, Glib maintenance, CRF design, and validation documentation
- Integrate protocol and charter requirements with internal business practices to draft Study Data Quality Plans
- Manage validation and deployment of new studies
- Plan and manage the update and re-validation of amended studies
- Delineate requirements and scheduling of data listings and patient data reports
- Liaise with Data Management, Clinical Operations, submission team, business development, and medical affairs groups
- Document activities and work according to SOPs. Write clearly and accurately
- Mentor junior colleagues, engender knowledge transfer
Qualifications:
- Bachelor's Degree in Life Sciences, Pharmacy or Nursing or equivalent experience
- Formal or on-the-job training in clinical trial methodology and Good Clinical Practice (GCP)
- Minimum of three years expert-level experience with Oracle Clinical, with the most recent being with Oracle Clinical/RDC 4.5.x
- Strong experience with Oracle Database administration activities
- Extensive CRF design experience, firm understanding of user interface design principles
- Team player who can multi-task, work effectively with members of other teams, and communicate productively with clients
- Experience in a regulated environment, especially pharmaceutical (21 CFR Part 11),
- Good time management and organization skills; the ability to prioritize own work to meet tight deadlines while maintaining the highest standards of work
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