Study Start Up Manager

 
ICON plc is a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries. The company specialises in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently, operates from 83 locations in 38 countries and has approximately 13,000 employees. Further information is available at www.iconplc.com

The Start-Up Manager is responsible for the coordination, execution and completion of the Start Up of Investigative Sites in their respective country in a timely manner with 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.

Job Description

• Recognize, exemplify and adhere to ICON's values around our commitment to People, Clients and Performance and bring those values to life to contribute to the propagation of the “Own It” culture at ICON

• Ensure delivery of start-up commitments against contractual obligations and 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 project level.  

• Accountable for appropriate resourcing and corresponding utilisation, including appropriate forecasting and headcount control, to ensure staffing levels are at all times conducive to operational and financial success. This includes participation in the hiring process.

• Work across the peer group to identify key talent to groom for succession planning in the country

• 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.

• Drive continuous Engagement and Enablement of direct reports to perform to their full potential by providing them with the required tools and guidance.

• Drive the overall delivery of the in-country start-up teams to drive execution of projects to exceed milestones and customer satisfaction, whilst ensuring quality and efficiencies.

• Ensure that budget parameters are adhered to for country-specific tasks to contribute to financial health of study.

• Facilitate increased productivity whilst maintaining quality levels.

• Provide oversight and line management for the study start up teams at country level.

• Provide effective management support to deliver a high performing culture including managing attrition, talent retention, development and engagement of the operational group.

• Carry out all relevant line management responsibilities including appraisals, goal setting and development plans.

• Manage the local Study Start Up team by empowering and coaching them to deliver their key objectives.

• 3+ years, including time spent in a start-up, site activation or regulatory environment, or other environment that would allow transfer of skill

• Japanese language fluency and high-level English is a must

• With a University degree in a healthcare, or science related subject, or extensive equivalent work experience, candidate will have had a successful career within the CRO/Pharmaceutical industry at manager level

• Prior people management experience

Benefits of Working in ICON
 
You will be working as a Leader with a great team of smart and energetic people.  ICON will offer you a very competitive management benefits package.  This does vary from country to country so a dedicated recruiter will discuss this with you at interview stage. 
 
We care about our people 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. 
 
What’s Next
 
Following your application, if you have the necessary skills and experience for this job you will be invited to an initial telephone interview with one of our dedicated recruiters who will be able to provide you with more details of this opportunity.
 
ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment