Lead QCO and risk management group within Clinical Operations department, including resource planning and process optimization.

Serve as functional SME within global clinical development group, represent function within vendor governance structure. Provide expert guidance in line with applicable regulations and business needs; author or contributor to SOPs and WIs.

Ensure clinical monitoring activities for Shionogi portfolio of studies are conducted in alignment with GCP/ICH, local regulations and Shionogi policies and procedures.

Oversee monitoring requirements for insourced studies conducted by Shionogi Inc.

RESPONSIBILITIES

• Review and assess trends across studies and develop action plans which result in continuous improvements to global processes and standards. Oversight and mitigation of trends will focus on critical safety and outcome data as identified per study Integrated Quality Risk Management Plans.
• Work collaboratively with CRO and other business partners to identify required process improvements which support oversight and quality management with a focus on efficiency and the use of risk based and remote monitoring strategies.
• Collaborate with internal, stakeholders (e.g., Biometrics, QA, RMC, Compliance, Clinical/Medical) to identify global metrics (KQI/KPI/KRI and QTL) to help assess monitoring quality for all studies.
• Proactively assess key quality and risk indicators across studies. Leverage metrics to assess risk and define appropriate thresholds. Support data driven decision making and risk mitigation strategies across functional teams.
• Ensure ongoing review of relevant data, metrics and reports from QCO function to support timely identification of emerging trends and creation of robust mitigation plans.
• Resource planning and management for QCO and RMC function including: hiring, training, performance management, and resource allocation. Serve as QCO and RMC SME within global and/or cross functional working groups to ensure alignment with global and local guidelines as well as latest industry best practices, and compliance with ICH/GCP requirements. Ensure Clinical Quality Control and Risk Management process is consistency applied across Shionogi portfolio.
• Lead QCO process for trend/signal detection, mitigation plan development and implementation to ensure ongoing ICH/GCP compliance across Shionogi portfolio of studies.
• Develop effective partnerships with functional service providers to ensure effective implementation of Shionogi processes and delivery of high quality data.
• Develop and maintain Clinical Quality Control and Risk Management process documentation.
• Represent QCO and Risk Management within Clinical Operations Leadership Team, contribute to process and resource optimization.
• Contribute to study plans (e.g., Monitoring Plan, Risk Based plan, Quality Plan).
• As necessary fill the role of Quality Control or RMC Lead for Global Studies.
• As needed participate in targeted QC of Trial Master File.

SUPERVISORY | DECISION MAKING AUTHORITY

Oversight of QCO and RMC functions and in-house CRAs, if applicable.

MINIMUM JOB REQUIREMENTS

• Bachelor’s degree in a relevant field; R.N. or equivalent. At least 10 years minimum experience in clinical research monitoring, preferably including knowledge of multiple therapeutic areas of relevance to assigned projects.
• Demonstrated ability to lead and influence
• Demonstrated ability to be versatile, serve as a role model to more junior clinical staff and 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.
• Will be expected to be in the Florham Park office 50% of working days/month.
• Willingness and ability to travel up to 50% of the time to investigative sites throughout the United States and occasionally internationally.

ESSENTIAL PHYSICAL & MENTAL REQUIREMENTS

• Ability to articulate clearly and conduct verbal presentations with large and small audiences.
• Ability to travel via automobile and/or airplane.
• Ability to view video display terminal images < 18” away from face for extended period of time – up to four (4) hours at a time.
• Ability to operate a computer keyboard and telephone.
• Ability to sit for extended periods of time – up to four (4) hours at a time.
• Ability to lift, tug, pull up to fifteen (15) pounds.

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

We look forward to reviewing your resume & qualifications.

DISCLAIMER

The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice.

EEO

Shionogi Inc. is an equal opportunity/affirmative action employer.

All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law.

It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.