Study Start Up Manager
About the role
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Study Start Up Manager
Office based in Ankara, Turkey
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 a Manager Study Start up at ICON, you'll work with coordination, execution, control and completion of Clinical Operations. Ensure delivery and development of the Study Start Up team against key metrics. Work with Leadership to develop and grow capabilities, productivity, and quality. We pride ourselves on our amazing company culture, where we work as one team to achieve industry-leading results.
The role
- Responsible for the coordination, execution, control and completion of the Start Up of Investigative Sites.
- Ensure delivery and development of the Start Up team against key metrics, 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 and KPIs enabling ICON to develop and grow the delivery of work at country, site and, if appropriate, at portfolio level.
- Facilitate increased productivity whilst maintaining quality levels.
- Provide direction and accountability for the operational teams and their delivery at the country and site level and provide input to higher level managers.
- Working within the clinical operations peer group to drive initiatives across the region and deliver these through their peers in their countries.
- Line management of assigned Study Start Up teams at country level.
- Resourcing, line management, training, functional delivery and input on discussions around quality and operational delivery measurements within the Clinical Operations group
- Conduct regular discussions with direct reports and lead team meetings at regional and manager team level.
- Contact for region in regard to operational questions and escalations.
- Work with Director/Senior Director and/or VP Clinical Operations to communicate all critical issues, business growth opportunities, developing key relationships as well as providing input regarding budgeting discussions to drive productivity and quality within the region.
What you need:
- Bachelor's degree
- Minimum 6 years Study start Up, Clinical Research experience that includes a minimum 4 years relevant experience as a SSUA, Senior CRA or Principal CRA (in a Lead CRA role), or at least 2 years as a Project Manager, CRA/SSU Manager or equivalent job role. Knowledge of ICH-GCP guidelines and ability to review and evaluate medical data
- Excellent management skills, developed with a collaborative approach to driving performance and success in a global environment
- Direct experience managing SSUA's / Clinical Research Associates is preferred
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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