Start-up Lead 3

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.

Our Study Start Up structure represents an integrated, dedicated, seamless team of experts, all striving to minimize cycle times. This is especially true of our dedicated and passionate Study Start Up Leads.

As a Start Up Lead, you will lead all aspects of Start Up activities at the regional level to achieve quick and successful activation of sites, overseeing and driving all aspects of study start up for your countries.

Working through until last site activated, you will lead and manage a team of In House CRAs (across a group of countries) who perform local EC submissions, prepare IP release packs and support sites at a local level. You will be working on a wide spectrum of projects in phase I-IV research at both GP practices and hospitals.
- Perform feasibility, site identification, site contract negotiation, and other study start-up activities, as assigned. Distribute and collect CDAs for potential study sites.
- Provide country-specific study start-up expertise to study start-up team leads and project teams. Create study start-up document templates.
- Responsible for the preparation and coordination of submissions to regulatory, ethics, and other bodies.
- Review and translate drug labels.
- Perform independent quality review of submission packages.
- Responsible for the translation and coordination of translations for documents required for submission.
- Perform timely and accurate data entry of all relevant study start-up activities into the appropriate CTMS.
- Copy and route incoming correspondence, internal documentation, etc, as appropriate.
- Responsible for the timely follow up for queries made by EC/competent authority (CA).
- Coordinate and create documents and material needed to support SIV
- Responsible for the collection of critical documents required for IP release.
- Responsible for the dispatch, negotiation, execution, and tracking of contract with sites and other sites, as appropriate.
- Responsible for the timely and accurate data entry of all relevant study start-up activities into the appropriate CTMS in assigned countries.
- Attend study team meetings as required, including Kick-Off Meeting.
- Responsible for the collection and maintenance of the current regulatory/CA and EC submission information and similar information for other related organizations in the assigned countries and update relevant client information system.
- To be familiar with ICH GCP, relevant country regulations/guidelines, and client SOPs.
- Competent in communication and influencing skills to ensure timely follow up, issue resolution, and report updates, as outlined in the communication and escalation plan with timely documentation.
- Perform regulatory document maintenance; amendments, periodic updates, and safety letters, where applicable.
- Develop and maintain effective relationships with local, regional, and country authorities.
- Comply with all department requirements regarding information provision and status updating and reporting.
- To undertake other reasonably related duties as may be assigned from time to time e.g. protocol amendment submissions, Investigator site budget negotiation, if required

2 - 4 years of experience required.

**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.