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Description
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Shionogi Inc. is the U.S. subsidiary of Shionogi & Co., Ltd., a leading Japanese pharmaceutical company. We are in a unique position of having the financial backing and the research capabilities of a well-established leading Japanese pharmaceutical company, matched with the entrepreneurial spirit of a start-up company.
Shionogi Inc. develops and commercializes pharmaceutical products that address unmet medical needs in the areas such as pain, women’s health and pediatrics. Together with our Japanese corporate parent, Shionogi has been providing innovative medicines essential to people's health for over 130 years.
We are seeking dynamic, focused and creative individuals to join our growing team. We are currently expanding our workforce in our New Jersey headquarters location and looking for experienced pharmaceutical professionals to help us build for the future.
The Contractor – Clinical Data Management works closely with our Biostatistics, Clinical Operations and Medical Affairs groups in all aspects of supervising CROs, setting up, managing and completing trials within timelines with the primary goal of ensuring data integrity. Additional responsibilities include assisting and working collaboratively with the Associate Director, Clinical Data Management, other Data Manager sand Shionogi Japanese Biometrics group in the development of global and local Data Management department standard working practices. This position entails partnering with cross functional groups, managing multiple trials and decision making responsibilities regarding trial designs, timelines, vendor selection, CRO oversight, etc.
DUTIES AND RESPONSIBILITIES
- Manage multiple studies and oversee CROs.
- Design CRF and write CRF Completion Instructions.
- Develop data management plans, edit check specifications, and data review plans. • Perform User Acceptance Test.
- Perform SAE reconciliation with the safety database.
- Write/resolve queries and track the status.
- Conduct review of clinical trial data and perform all tasks required for database lock.
- Support the Manager of Data Management.
- Respond and provide trial related support to cross functional groups such as Biostatistics, Clinical Research, etc.
- Assist in developing SOP and Working Practices.
- Attend meetings and report on study status, metrics, timelines, etc.
- Other data management department and trial related activities as delegated.
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Requirements
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MINIMUM JOB REQUIREMENTS
- BA/BS in science related field.
- 7+ years’ experience in pharma/biotech industry.
- Proficiency with CDASH, SDTM and medical terminology.
- Good working knowledge of GCP.
- Clinical data management background with EDC systems (ex. Medidata Rave).
- Strong project management skills.
- Excellent, verbal, written and interpersonal communication skills.
- Prior experience overseeing CRO.
- Must live a commutable distance from NJ Corporate offices.
Other Preferred Skills
- Knowledge in JReview.
- Basic SQL and or SAS knowledge.
- Experience with eDiary technology.
- Supervisory experience is a plus.
To be considered for this position, you must apply online at www.shionogi.com and meet the requirements of this opportunity.
We look forward to reviewing your resume & qualifications.
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