Senior Regulatory Affairs Specialist / Senior Study Start Up Specialist / Clinical Site Contracts & Submissions Specialist - Hybrid - Romania
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
As a Principal Study Start-Up Associate at ICON, you will lead clinical trial start-up activities, overseeing CTA negotiations, regulatory submissions, and payment processes to ensure timely and efficient study activation.
What You Will Do:
Your focus will be execution and oversight of clinical trial country submissions and approvals and negotiations of budgets and CTAs with sites.
Key responsibilities include:
Leading the preparation and submission of essential documents for regulatory approvals and site activation.
Development, negotiation and completion of Clinical Trial Research Agreements
Oversees and tracks clinical research-related payments. Payment reconciliation at study close-out
Providing guidance and support to study teams and sites during the start-up phase, fostering effective communication and collaboration.
Staying current with industry regulations and trends to enhance start-up strategies and best practices.
Your Profile:
You will have solid site start-up and activation experience, with the ability to manage competing priorities and develop your team.
Required qualifications and experience:
Bachelor's degree in a relevant scientific discipline or healthcare-related field
Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes.
Extensive experience in study start-up activities within the clinical research industry, with a strong understanding of regulatory requirements.
Excellent organizational skills and attention to detail
Strong communication and interpersonal skills
Comfortable with a hybrid schedule requiring 1–3 days per week in the office.
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Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here
Are you a current ICON Employee? Please click here to apply
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times.
We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
