Overview
As a Senior Study Start Up Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Your key responsibilities will be the preparation and the submission of the submission package to the Ethics Committee, including the local Informed Consent Form preparation.
Responsibilities
Responsibilities include:
- 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.
- Develop, finalize, and review master and country-specific subject information sheets (SIS)/ICFs.
- 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
Qualifications
You will need:
- 2 – 4 years of experience in a Study Start Up role
To be familiar with ICH GCP, relevant country regulations/guidelines
Competent in communication and influencing skills to ensure issue resolution
Ability to Perform regulatory document maintenance; amendments, periodic updates, and safety letters, where applicable.
Experieence in developing and maintain effective relationships with local, regional, and country authorities.
Ability 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
Candidates must be based in Sweden, with fluent Swedish language skills and strong knowledge of Swedish clinical regulationsWhat ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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.
https://careers.iconplc.com/reasonable-accommodationsInterested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
