Study Start Up Manager

Location: Dublin, Ireland or UK (home or office based)

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