Associate Reg & Start-Up Director

Job Overview
Direct Global Site Activation 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.

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 guide line 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 Life sciences or related field
• 10 years’ relevant experience including at least 3 years in a lead position within Study start up/site activation or execution and demonstrable experience in an international role. Equivalent combination of education, training and experience.
• Excellent negotiation and communication skills with ability to challenge
• Excellent interpersonal skills and strong team player
• Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects and programs.
• Thorough understanding of regulated clinical trial environment and in depth knowledge of drug development process
• Demonstrated proficiency in using systems and technology to achieve work objectives
• Excellent regulatory and/or technical writing skills
• In-depth knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines
• Excellent leadership skills, with ability to motivate, coach and mentor
• Excellent organizational and planning skills
• Proven ability to exercise independent judgment taking calculated risks when making decisions
• Excellent presentation skills
• Proven ability to establish and maintain effective working relationships with co-workers, managers and sponsors
• Strong financial acumen
• Proven ability to work on multiple projects balancing competing priorities

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.