Manager, Study Start Up

Manager, Study Start Up

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

As Study Start Up Manager, you will lead a team of Study Start Up Associates within the EMEA Region. This will include the coordination, execution, and completion of the Start Up for the selected Investigative Sites in the allocated country(ies) in a timely manner with highest quality. It 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, in accordance with ICH, GCP and all applicable regulations, laws and other guidelines and ethical standards. You will ensure that study authorization roles and responsibilities are focused on quality optimization, efficiencies and cost containment.

Role Responsibilities include:

• Recognize, exemplify, and adhere to ICON's values and bring those values to life to contribute to the propagation of the “Own It” culture at ICON.
• Accountable for appropriate resourcing and corresponding utilisation, including appropriate forecasting and headcount control, to ensure staffing levels are always conducive to operational and financial success.
• Provide oversight and line management for the assigned study start up team members at country level and their Operational Delivery
  • Ensure delivery of start-up commitments against contractual obligations and key metrics, with a focus on quality, efficiency and reduction in cycle time compared to industry standard.
  • Carry out all relevant line management responsibilities including the selection and recruitment of suitable and qualified staff, appraisals, goal setting and development plans. Mentor staff, encourage growth and provide regular performance feedback.
  • Continually assess opportunities for process improvements and develop and monitor process change implementation.

Your background and experience. You will likely have a blend of the following skills:

• Educated with a degree in Life Sciences or healthcare and proven clinical research industry experience.
• You will have had a career to date which will have included time spent in a start-up, site activation or regulatory environment, or other environment that would allow transfer of skills.
• In a highly regulated environment and tight timelines to open study sites you should have effective communication and prioritization, risk assessment, problem solving and decision-making skills and ability to collaborate cross-functionally and/or with clients. Given that this role involves line management, you will have strong mentoring, team management and leadership skills.

Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

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