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Oracle Clinical Study Designer CoreLab Partners
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
| Location: | 100 Overlook Center Princeton, NJ 08540 United States |
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CoreLab Partners
Investors: Adams Street Partners, Siemens Venture CapitalAll Jobs: at CoreLab Partners
| Web Site: | www.corelabpartners.com |
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| Headquarters: | 100 Overlook Center Princeton, NJ 08540 United States |
| Industry: | Healthcare Services |
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