Associate Director Regulatory and Start Up at IQVIA

Job Description

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