Oracle Clinical Study Designer

At Kforce Clinical Research, we dont just offer jobs. We offer a rewarding career experience, complete with professional development opportunities and a great benefits package! We are intelligent business partners to some of the worlds most valued pharmaceutical companies and have evolved to create models of operational excellence that incorporate Lean and Six Sigma philosophies. Using these tools, Kforce is able to better plan and anticipate work loads and thus minimize the peaks of work that can swamp you. This allows you to stay just as dedicated and still strike a balance between work and home. Currently, one of our top clients is in search of an exceptional Oracle Clinical Study Designer in Princeton, NJ. The Oracle Clinical Study Designer designs and creates 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. Specific Accountabilities: * Design, create, and validate new studies in Oracle Clinical to 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, the submission team, business development, and medical affairs groups * Document activities and work according to SOPs * Write clearly and accurately * Mentor junior colleagues and engender knowledge transfer Requirements: For you to be the successful candidate we are looking for in this role you must possess: * Formal or on-the-job training in clinical trial methodology and Good Clinical Practice (GCP) * Minimum of three years of expert-level experience with Oracle Clinical (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 ability; able to 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) For consideration, you must possess a Bachelors degree in Life Sciences, Pharmacy, Nursing, or equivalent experience. Due to the precise requirements of this position, we will only be contacting candidates that meet all of the listed criteria. Kforce Clinical Research has been serving the pharmaceutical industry since 1988. We are truly a career destination and the employer of choice for skilled, dedicated professionals like you. At Kforce, one of our core principles is: Great People = Great Results!

Please refer to job code 1696NRC950566T199 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Clinical Research
Location:	Princeton, NJ
County:	Mercer County
ZIP Code:	08540
Pay Rate:	Open
Job Terms:	full time
Company:	Kforce Inc.
Phone:	email only please
Fax:	email only please