ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
Working directly with Investigative Sites, this role will independently manage and perform activities at a site level associated with study start-up including regulatory document collection, preparation of ethics submission documents, informed consent review and essential document package review. Reporting to the Site Activation Strategist, the Start Up Manager must have an in-depth understanding of study start-up activities and associated regulatory requirements.
- Build, cultivate and manage relationships with key study personnel, including Study Coordinators
- Work directly with Investigative Sites for all aspects of study start-up including: activation timeline development, regulatory document preparation and collection, IRB/EC submissions and informed consent review
- Draft and respond to IRB queries and facilitate responses to EC queries
- Create, review and customization of country/site specific Informed Consent Forms (ICFs)
- Negotiate site contracts and budgets, as necessary
- Manage translations of relevant study documents
- Manage the Clinical Research Organization/Functional Service Provider for outsourced tasks
- Manage and track issues and escalations to internal stakeholders
- Develop start-up plans and oversee the execution of plans for assigned sites.
- Proactively identify site challenges and implement appropriate mitigations
- Manage feasibility and/or site identification activities for assigned sites
- Work directly with key internal client personnel to share information, manage and triage issues
- Bachelor’s degree with a major in a related field and experience in study start-up In-depth knowledge of start-up processes and procedures
- Must have good working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines
- Experience with investigative site start-up documents
- Good understanding of clinical trial execution
- Fluency in English
Key Competencies Required
- Ability to work under pressure to meet deadlines
- Self-motivated and ability to work well independently and in a team environment
- Ability to effectively manage multiple priorities
- Excellent project management skills
- Meticulous attention to detail and process oriented
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, 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.