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.
Study Start Up Lead is responsible for country study start up (SSU) activities and performing quality review of essential documents. The SSU Lead is responsible for overseeing and leading SSU activities in collaboration with country team members (CLM and CRA) with the objective to improve site activation and maximize patient recruitment time.
The SSU Lead is responsible for the start-up of clinical trial activities in their assigned country/countries to achieve greenlight for selected sites. SSU Lead also performs quality review of essential documents at start up and during the lifecycle of the study, ensuring adherence to ICH-GCP guidelines and local requirements Responsibilities:
- Interact with site and study personnel to collect country specific documents such as IRB/IEC approvals, financial disclosure, CVs/medical licenses, etc. and review for accuracy, completeness and adherence to ICH/GCP
- Perform quality review of country and site level essential documents following a risk-based approach, issue queries, and communicate outcome to identified users at key milestones and during the course of the study
- Prepare and submit regulatory and IRB/IEC documentation as required per country requirements during the course of the study
- Preparation, tracking, and distribution of site start up documentation including Investigator Site File
- Obtain any required approvals for relevant site document (e.g. informed consent, financial disclosures) to ensure start up timelines are met
- Manage oversight, in collaboration with CLM, of country and site start up activities and eTMF quality using Vault Clinical reports and dashboards
- Assist with audits/inspections of relevant start up activities and/or eTMF
- Attend and actively participate in team meetings by providing site greenlight projections and timelines
Benefits of Working in ICON:
- The incumbent should have a Bachelor’s degree (or equivalent experience) and minimum of 2 years of experience in clinical development including start up/ regulatory process experience
- Knowledge of study start- up processes
- CTAs that work with start- up are welcome to apply
- Regulatory background ,regulatory submissions experience is an advantage
- Local regulatory authorities experience
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.