Assoc Dir Reg & Start Up FSP EMEA
Detail de l'annonce :
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