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Sr. Manager of Clinical Development
Shionogi USA is the US subsidiary of a leading Japanese pharmaceutical company, Shionogi & Co., Ltd. We are in the 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. Our US pharmaceutical development team is expanding in multiple areas and we need a talented Study Manager to join our team – a group of talented professionals whose experience comes from a wide range of US pharmaceutical companies.
Responsibilities
• Participate in the design, planning and implementation of clinical research projects which includes establishing processes and procedures for the proper coordination and oversight of clinical trials.
• Assist with protocol development and design of case report forms.
• Provide contract and budget oversight of Contract Research Organizations (CROs); managing the CRO to meet proposed study timelines.
• Evaluate and select investigators and coordinate their activities to assure compliance with protocol and clinical objectives.
• Review data (i.e., interim analysis and tracking tools from CRO to track progress of data entered and cleaned).
• Draft and review reports (i.e., communication plans, monitoring reports and plans, charges for vendors, investigator manual, procedure manuals)
• Monitor clinical trials through site visits as needed.
Qualifications
• BA/BS in life sciences or equivalent; or RN/BSN. Advanced degree or certification a plus.
• At least 7 years clinical research experience including having led a project from inception to completion coupled with demonstrated ability to effectively lead a project and hold team members accountable.
• Prior experience working for a CRO is strongly preferred.
• Strong written and verbal communication skills along with excellent interpersonal skills.
• Proficient computer skills and knowledge of standard office software (Microsoft Office)
• Demonstrated ability to resolve multifaceted problems and lead projects of diverse scope analyze data and exercise sound judgment.
• Willingness to travel approximately 10% of time including possible international travel.
Shionogi USA offers a competitive compensation package and a comprehensive benefits program. For consideration, please email your resume/CV to recruiting@tds.net . We are an Equal Opportunity Employer.
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Position Type:
Employee
Ref Code: 03 |
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