Post: Senior Clinical Trial Manager –Clinical Development Operations
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 anti-infectives. 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 Senior Trial Manager Clinical Development / Operations will oversee and manage all operational aspects of phase I – IV global clinical trials in order to achieve a high quality product for the marketplace and business success for Shionogi Inc.
- Responsible for leading a global cross functional team in the planning and delivery of a defined clinical project to scope, quality, budget, time, managing resource and risk.
- Responsible for project management including the development and maintenance of realistic, up to date and appropriate quality, project and study plans (including timelines and budget).
- Contribute to and support selection of all study-related vendors.
- Provide input into study feasibility, study specifications, vendor/partner contracts and essential documents such as clinical study protocols, informed consents, CSRs, etc.
- Manage a clinical study and the associated processes to identify and solve operational issues and drive delivery to plan through internal or external partners (i.e., CROs).
- Act as operational interface with external (e.g. CRO) partners. Manage relationship to ensure successful delivery of all study lifecycle deliverables (RFP through completion of the Trial Master File).
- Review and approve contracts, work orders and invoices prior to submission to senior management for approval.
- May be assigned responsibility for management of non-drug project work
- Establish and maintain effective communication and collaboration with functional area peers, in order to meet program objectives and support achievement of goals.
- Responsible for participating and presenting at Investigator Meetings.
- Responsible for preparing and/or presenting executive management slide decks.
- BA/BS in life sciences or equivalent; or RN/BSN. Advanced degree or certification a plus.
- At least 6 years of clinical research experience including at least three (3) years having effectively led a project from inception to completion coupled with demonstrated ability to hold team members accountable.
- Extensive knowledge of clinical operations, project management tools and processes.
- Proven ability to learn by working in multiple phases, TAs and/or different development situations.
- Demonstrated expertise in daily oversight of CRO relationships and activities and a track record for completing trials on time and within budget.
- Significant knowledge of pharmaceutical business, drug development and regulatory processes.
- Demonstrated ability to resolve complex problems and lead projects of diverse scope, analyze data and exercise sound judgment along with the ability to recommend business alternatives to senior management.
- Strong management and collaborative skills with demonstrated ability to effectively mentor clinical trial staff
How to apply:
To be considered for this position, you must apply online at: https://www.shionogi.com/careers/careers.html — and meet the requirements of this opportunity. We look forward to reviewing your resume & qualifications.
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