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Executive Director, CRO Business Unit Operations Management

Morrisville, NC, USA | INC Research

  • Industry:
    Pharmaceutical / Biotech
  • Position Type:
    Full-Time
  • Functions:
    General Management
    Operations / Production
  • Experience:
Job Description:
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Provides senior level direction and management associated with the Company’s business operations, ensuring the Company’s TrustedProcess™ methodology, project management practices, and Standard Operating Procedures (SOPs) to ensure internal and Customer quality standards, Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines and all federal and local regulations are fulfilled.Provides strategic and opeational level planning.Drive ‘positive change’ throughout the company through effective participation in continuous process improvement program.


Essential Functions: 


Participates in both short and long-term planning for all aspects of the Company’s operations and growth.Contributes operational input to other departments as appropriate, including developing and distributing appropriate reports to executive management. 


Manages the forecasting, planning and logistics for clinical operations activities, including the direction and scheduling of clinical operations resource allocations, ensuring performance and quality standards are met.Reviews performance of the Company’s activities and makes recommendations for improvement in quality/efficiency.Periodically, participates in conducting annual site evaluations.  


Reviews and provides input on study proposals, while participating in the sales and marketing function as it relates to the Company’s clinical operations activities.Participates as a primary source of operations information in the budgeting process for clinical studies and the department.


Liaison and facilitator between the Company’s operation’s departments and clinical business units for project related tasks and/or issues. Plans and negotiates resources with line management of functional areas.Serves as a Project Advisor on project teams by providing input regarding the operational and project management aspects of the projects. 


May develop and refine project management processes within the Company, using established process modeling techniques. Leads teams of subject matter experts to develop and review SOPs and WIs related to any area concerning project management to support new or existing project management processes.May work with the Project Manager on the study start up and financial management tasks of a project to ensure success of the overall project.Implements enterprise wide project management systems and tools.Evaluates project progress, while producing and distributing resource status reports as well as functional area plans, to appropriate members of executive and senior management. 


Ensures thorough clinical study feasibility and appropriate distribution of studies to consortium sites.Develops, collects, and analyzes project metrics, while holding project reviews with operational staff focusing on budget, schedule and risk analysis.  


Manages the development of clinical research capabilities within the Company’s member sites as performed through leadership and management of field operations activities as required. Implements global project management systems and processes to increase efficiency.Plans for the efficient allocation of resources within operations. 


Ensures compliance with GCP sponsor contracts as well as all Food and Drug Administration (FDA) and ICH requirements.Develops and implements policies, procedures and SOPs for clinical operations activities, as well as applicable training programs for staff and network sites.Interacts with senior management of pharmaceutical and biotechnology sponsors on operational issues.


Within the department, approves courses of action on all management / human resources’ matters, including salary administration; employment hires, transfers, terminations; performance appraisals and professional development; job description preparation, and employee counseling.Works with and advises staff on administrative policies and procedures, technical problems, priorities and methods.


Other Responsibilities:


Performs other work-related duties as assigned. Moderate travel may be required (up to 50%). 


Interview candidates for positions in project teams.Represents the Company at professional meetings or seminars. Establishes and maintains training materials for project managers.Provide input and requirements for long range IT/enterprise plans. 


BA/BS degree or equivalent combination of education and experience; and extensive senior management experience preferably in a worldwide clinical research, pharmaceutical, or biotechnology company.MBA; or other relevant advanced degree preferred.Comprehensive management skills and experience, including but not limited to short and long-term planning, evaluation, directing and motivating staff, marketing and financial management.Thorough knowledge of FDA regulations, drug development, and clinical project management procedures is required.


Additionally experience developing and setting corporate plans and objectives that support the organization’s worldwide drug development processes, while making critical decisions related to changing the direction of the business is essential.Must have a record of engaging diverse interests for the common good; adept at marketing and able to communicate and work with a diverse group of individuals to accomplish common goals.Membership and/or affiliations with applicable professional organizations related to the Company’s business are highly preferred.Highly effective strategic planning, communication, written, presentation and analytical skills.Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), email, and voicemail is required.Experience working in a matrix team environment is preferred. 


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