Study Start Up Manager
Location: Dublin, Ireland or UK (home or
office based)
At ICON, it’s our people that set us apart.
As a global provider of drug development
solutions, our work is serious business. But that doesn’t mean you can’t have
fun while you do it. With our vision to be the partner of choice in drug
development, we hire only the best and brightest in the industry. Are you one
of them?
As the Start-Up Manager you will be
responsible for the coordination, execution and completion of the Start Up of
Investigative Sites in their respective country in a timely manner with the
highest quality. This involves driving cycle times from Final Approved Protocol
(FAP) to site activation, including key activities such as critical document
package (CDP) collection, EC/IRB submission/approvals, ICF development, and
budget and contract negotiations. The processes will be consistently validated
with predictability of CDP completion, timely site initiation visits, and
reduced cycle times compared to industry standards.
The Role
·
Ensure delivery of start-up commitments
against contractual obligations, including but not limited to, predictability
of CDP completion and SIV date, as well as reduction in cycle time compared to
industry standard.
·
Drive the completion and delivery from Final
Approved Protocol to site activation through a variety of metrics enabling ICON
to develop and grow the delivery of work at country, site and project level.
·
Line management of assigned Study Start Up
Associates at country level; including conduct and documentation of regular 1:1
discussions with direct reports, and leading team meetings.
·
Contribute to professional development of the
Start Up associates.
·
Deliver in-function and cross-functional
training as required.
What you need
·
Understanding of SSU submissions and
contracts processes in Ireland and the UK with direct proved experience in this
area, and ability to drive the SSU operations within the current team
·
Ability to motivate the team and the
operational and communication skills to identify risks
·
Think of a mitigation plan and communicate
timely the issues and the solution to the right partners
·
A Bachelor’s Degree or local equivalent
and/or appropriate experience from the Medical/science background and/or
discipline.
·
A minimum of 3 years of experience in SSU,
including time spent in a start-up, site activation or regulatory environment,
or other environment that would allow transfer of skills.
·
You will possess excellent written and verbal
communication skills in English
Benefits of Working at ICON
Other than working with an outstanding team
of ambitious people, we also offer a very competitive compensation package.
This varies from country to country so a dedicated recruiter will discuss this
with you at interview stage.
We care about our employees as they are the
key to our success. We provide an open and friendly work environment where we
empower people and provide them with opportunities to develop their long term
career.
ICON is an equal opportunity employer and
committed to providing a workplace free of any discrimination or harassment.
EOE race/color/religion/sex/sexual
orientation/gender identity/disability/vet/national origin
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