Posted to MedZilla on 4/30/2017


US-NJ, Senior Manager Clinical Quality Control Clinical Operations 17_0010-MZ


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 Manager Clinical Quality Control will lead a group of Quality Control representatives who are responsible for coordinating and performing comprehensive Quality Control (QC) of CRO managed investigative sites. As needed, perform site management of Shionogi clinical trials.


  • Develop and maintain Quality Control process documentation.
  • Work closely with Global Trial Managers to manage workload of Quality Control Representatives against portfolio requirements.
  • Ensure Quality Control is consistency applied across studies/ programs.
  • Provide input into study plans (i.e., Monitoring Plan, Quality Plan).
  • As necessary fill the role of Quality Control Lead for Global Studies.
  • Perform Quality Control activities:
    • Oversee and evaluate CRO monitoring activities through electronic data capture (Medidata Rave), electronic diaries ), patient enrollment , site monitoring, review of monitor visit reports and review of status in CRO CTMS.
    • Perform QC of CRO Monitor Visit Reports; maintain issue and resolution log.
    • Conduct QC visits at investigative sites, identify and follow-up on site action items, prepare QC visit report.
    • As requested coordinate and perform site booster visits and co-monitoring visits.
    • Attend and/ or participate in investigator meetings (planning, execution and presentations).
    •  Interface with investigators, study coordinators, and study personnel via telephone, written correspondence and on-site visits.  
  • As needed, perform CRA Monitoring Responsibilities for Shionogi clinical studies:
    • Interface with investigators, study coordinators, and study personnel via telephone, written correspondence and on-site visits.
    • Coordinate and disseminate information to site staff (i.e., study protocol, CRFs). Monitor study protocol(s).
    • Collect and review regulatory documents and perform source document verification.
    • Provide verbal reporting of any serious adverse events related to the study project.
    • Complete trip reports and other required forms. Provide documentation for related correspondence.
  • As needed participate in targeted QC of Trial Master File.
  • Manage a team of field based Clinical Research Associates.


  • Bachelor s degree in a relevant field; R.N. or equivalent.
  • 7 years minimum experience in clinical research monitoring.
  • Knowledge of multiple therapeutic areas of relevance to assigned projects is preferred.
  • Demonstrated ability to lead and influence.
  • Demonstrated ability to be versatile, serve as a role model to more junior clinical staff, and have a willingness to teach others as evidenced by a collaborative work style.
  • Knowledge of Word, Excel, PowerPoint and Microsoft Office.
  • Strong working knowledge of Good Clinical Practices (GCPs) and pertinent U.S. FDA Code of Federal Regulations.
  • Demonstrated ability to attend to detail, make effective presentations and work independently.
  • Ability to travel independently by air, car and/or train.
  • Willingness and ability to spend prolonged periods of time reviewing medical charts and data collection forms, and utilize a small screen laptop computer.
  • Must live in the NY/NJ area Will be expected to work physically in the US Corporate offices in Florham Park, NJ at least one day per week.
  • Willingness and ability to travel up to 50% of the time to investigative sites throughout the United States and on occasion, internationally.

To be considered for this position, you must apply online at: -- and meet the requirements of this opportunity.

We look forward to reviewing your resume & qualifications.

  • We are an Equal Opportunity Employer.
  • Please view Equal Employment Opportunity Posters provided by OFCCP here.

Please visit our website at


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  considered, please do so. Applications for all positions are subject to each employer's specific requirements.