Study Manager I

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.

• Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance.
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Travel (approximately 5%) domestic and/or international.
• Perform duties under general supervision of the Department Manager, the Director, Clinical Operation, Medical Director and PI and be responsible for all aspects of the clinical study for the life of the project.
• *Work with cross-functional sections/teams to deliver clinical study projects under the constraints of study scheduling and resources.
• Ensure adequate staffing and training of staff working on assigned projects.
• *Act as the primary liaison between the project team and the client.
• *Ensure that all outside vendor contracts are set up and deliverables are being meet in accordance to the agreed upon work order.
• *Obtain and review clinical statement of work (SOW) and/or study work order (SWO) to determine what services are required for each clinical trial protocol.
• *Initiate and participate in the early planning phases of clinical study by providing guidance on deliverables and outsource options (i.e. assist in preparation of study proposal timelines, scheduling and other study requirements as appropriate); including but not limited to study source documents, procedural timelines and lab set up.
• Work closely with clinical research coordinator to ensure adequate internal resources and resolution of any clinical study work flow issues for assigned clinical studies.
• Prepare and maintain project management plan for assigned clinical studies.
• Act as liaison and point of contact for all clinical study sponsors and vendors for related services.
• Attend sponsor meetings and required conference calls to ensure effective communication flow between external customers and staff.
• *Present at Clinical Tracking Meetings.
• Lead and/or participate in all IDS study related meetings to include (clinical tracking, screen team and mock runs).
• Initiate Team Meetings as required.
• *Track and monitor all clinical study change requests; providing information to all appropriate internal study team members.
• Work with IDS clinical studies unit and external vendors to discuss deliverables and timelines and communicate timelines to sponsor.
• To undertake other reasonably related duties as may be assigned from time to time.

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.