Senior Manager Clinical Management

Job Summary

Under the direction of the Director/Associate Director of Clinical Management the Senior Clinical Study Manager is responsible for the oversight and management of Otsuka clinical studies including coordination with other relevant parties (e.g. other Otsuka departments external service providers (ESPs) etc.). Responsibilities include the planning execution and completion of clinical trials according to applicable regulations and guidance; ICH Guidelines Good Clinical Practices (GCP) and Otsuka SOPs within agreedupon timeframes and budget.

Job Description

• Provides oversight and management of clinical studies at Otsuka including planning execution and completion of clinical trials according to all applicable regulations and guidance ICH/GCP and Otsuka SOPs.
• Contribute to the development and review of all critical clinical study documents including clinical protocols informed consent forms or other studyrelated clinical documents.
• Provide input into and approval of the identification evaluation and selection of CROs outside vendors (e.g. central labs central IRB IVRS etc.) and investigative sites.
• Provide leadership and guidance to clinical team to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; ICH GCP and Otsuka SOPs.
• Communicates and coordinates clinical projectrelated activities and progress across all relevant crossfunctional departments.
• Provide management personnel with timely updates on progress and changes in scope schedule and resources as required.
• Participate in forecasting study expenditures and resourcing needs.
• Ensure internal clinical team and vendors manage and monitor studyrelated budget and expenses to meet forecast.
• Provide timely communication of any variances in budget forecast to the Director/Associate Director.
• Establish communication flow with CRO and investigative sites to maximize compliance with study protocol.
• Provide oversight of ESP in its conduct of the daytoday operations of assigned trial(s) as assigned.
• Participates in ongoing review of clinical trial data focusing on data integrity trending and consistency.
• Supports project level inspection readiness activities including responsibility for ensuring the completeness timeliness and quality of the TMF.
• Serve as Clinical Management representative for review of protocols within and across portfolios as assigned.
• Participate in programlevel risk mitigation strategies and collaborate with ESPs on studylevel risk mitigation and management activities.
• Represent Clinical Management in departmental and crossfunctional initiatives as assigned.
• Leads and/or contributes to assigned departmental ESP and corporate standardization and continuous improvement efforts.
• May have supervisory responsibilities including:
• Coordinating the training and onboarding of new employee(s) on corporate culture corporate goals/vision and departmental policies and processes.
• Assuring compliance with departmental SOP compliance and corporate training
• Ensuring assigned staff have access to all required materials systems and training to complete job responsibilities.
• Setting clear performance expectations and individual development plans and providing specific and frequent feedback to the employee on his/her performance.
• Performs other duties as assigned.
  
  

Qualifications/ Required

Knowledge/ Experience and Skills:

• Comprehensive knowledge of clinical operations drug development process roles and responsibilities of individuals within the project team standard operating procedures (SOPs) and GCP/ICH regulations.
• Thorough knowledge of contract research organizations (CROs) outsourcing and evaluation of work performed against vendor Statement of Work (SOW).
• Strong understanding of the clinical and scientific basis for assigned clinical program with the ability to translate that knowledge in operational management.
• Strong understanding of global regulatory requirements.
• Strong communication organization planning analytical problem solving and people management skills.
• Demonstrated experience with working with the Microsoft suite of programs (e.g. Word Excel PowerPoint Outlook etc.)
• Good understanding of clinical trial related software (e.g. eCRFs IRT CTMS etc.).
• Ability to travel up to 25%.
  
  

Educational Qualifications

Required:

• Bachelor’s Degree or Registered Nurse (RN). Minimum of 10 years industry experience with seven (7) years in clinical trial management experience.
  
  

Preferred:

• Previous supervisory experience.
  
  

Competencies

Accountability for Results Stay focused on key strategic objectives be accountable for high standards of performance and take an active role in leading change.

Strategic Thinking & Problem Solving Make decisions considering the longterm impact to customers patients employees and the business.

Patient & Customer Centricity Maintain an ongoing focus on the needs of our customers and/or key stakeholders.

Impactful Communication Communicate with logic clarity and respect. Influence at all levels to achieve the best results for Otsuka.

Respectful Collaboration Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.

Empowered Development Play an active role in professional development as a business imperative.

Minimum $143340.00 Maximum $204930.00 plus incentive opportunity: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate’s job experience specific skills and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.

Company benefits: comprehensive medical dental vision and prescription drug coverage company provided Basic Life AD&D Shortterm and Longterm Disability insurance tuition reimbursement a 401(k) match PTO allotment each calendar year paid holidays and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings;

Disclaimer:

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race color sex gender identity or gender expression sexual orientation age disability religion national origin veteran status marital status or any other legally protected characteristic.

If you are a qualified individual with a disability or a disabled veteran you may request a reasonable accommodation if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request.



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