Associate Director Regulatory and Start Up

Job Overview

Direct Site Management operations for a designated (sub-) region or a defined function within the (sub-) region. Develop plans to ensure the allocation of human, material, system and fiscal resources for assigned area of accountability. Determine strategic goals and objectives for designated (sub-) region and/or function ensuring operational alignment with senior management priorities. Lead (sub)-regional and/or functional strategic initiatives and work with senior management across disciplines to develop implementation plans.

Home Based role requiring fluency in English.

Essential Functions

• Manage staff in accordance with organization’s policies and applicable regulations.
• Responsibilities include planning, assigning, and directing work.
• Appraising performance and guiding professional development.
• Rewarding and disciplining employees.
• Addressing employee relations issues and resolving problems.
• Approve actions on human resources matters.
• Direct the hiring and selection process for a function/ (sub-) region or office and work collaboratively with senior management to set targets for recruitment and retention across roles.
• Contribute to the formulation of effective strategic goals for Site Activation operations across (sub-) regions.
• Take ownership for strategic initiatives within assigned unit of accountability including development of measures for success.
• Provide leadership to ensure service offerings meet or exceed customer expectations.
• Ensure the improvement of the execution of Site Activation processes.
• Manage operational delivery to achieve outputs to pre-defined targets. Contribute to the provision of strategic leadership and approval for the resourcing process and outcomes, hiring targets and processes and onboarding and training standards.
• Provide a leadership role in resourcing process through continual evaluation of existing and future resource alternatives, pro-active planning and collaboration with Site Activation leadership and operational peers.
• Evaluate regional/functional workload, quality and budget metrics through regular review and reporting of findings.
• Collaborate with senior management and other functional leadership to improve efficiencies, project outcomes and quality metrics for Site Activation projects.
• Act as a coach and mentor for managers as they develop in their role.
• Work collaboratively with client representatives and other functional (site management) leadership to manage project related challenges and to achieve exemplary customer service.
• Pro-actively plan for appropriate Site Activation operations budget consumption and guideline managers in managing variances and in developing corrective fiscal action plans.
• Effectively communicate and describe all Site Activation service offerings to internal and external customers.
• Ensure quality and regulatory appropriateness and acceptance of all service offerings.
• Lead corporate or departmental quality or process improvement initiatives.
• Act as a client liaison for Site Activation function.
  
  

Qualifications

• Bachelor's Degree Healthcare or other scientific discipline preferred Req
• 10 years of clinical trials experience including 6 years’ experience in a leadership capacity.
• Full knowledge of the drug development process
• Full knowledge of applicable regulatory requirements, Standard Operating Procedures (SOPs), and company’s Corporate Standards
• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
• Excellent knowledge of budget management and resourcing
• Considerable working knowledge of medical terminology
• Excellent negotiating skills
• Ability to lead and motivate teams
• Ability to independently coordinate and manage new processes
• Ability to handle management/personnel issues
• Ability to work independently and to effectively prioritize tasks
• Ability to work within a matrix team environment
• Ability to establish and maintain effective working relationships with co-workers, managers and clients
  
  

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com