Assoc Dir, Reg & Start Up, FSP, EMEA

작업 내용

IQVIA FSP EMEA Team has an opportunity available for an Associate Director in Regulatory and Start Up. This individual will need to have global experience in Regulatory and Site Activation.

Open to location in EMEA

Position will be homebased

The individual will provide operational support to the Clinical Research organization to ensure the wellbeing of clinical research subjects and the best possible project outcomes.

Manages and executes the site identification process and performs regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements either at the global, regional, or country level.

Prepares and manages site regulatory documentation; reviews and negotiates site regulatory documents and contracts with sites and sponsors; maintains, reviews, and reports on site performance metrics; serves as the primary point of contact for investigative sites; tracks completion of regulatory and contractual documents for sites; ensures contracts are fully executed; and establishes project timelines.

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.

Responsibilities

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.

Experience : Typically requires a minimum of 5 - 7 years of prior relevant experience.

Knowledge : Requires practical knowledge in leading and managing the execution of processes, projects and tactics within one department or multiple related departments.

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. Learn more at

https://jobs.iqvia.com