Study Start Up Associate Ii

10 hours ago

Bengaluru Karnataka, India ICON Plc Full time

Study Start-Up Associate-II

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

We are currently seeking a Study Start Up Associate II to join our diverse and dynamic team. As a Study Start Up Associate II at ICON, you will play a pivotal role in leading the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of inNvative treatments and therapies.

Roles & Responsibilities:
You will be a key member of the Study Start-Up team. You will:
- Interact successfully with both internal and external customers- Exhibit good decision making skills, utilizing all available resources to achieve positive outcomes- Communicate with investigative sites and internal team members to predict timelines for site activation and ensure all activation requirements are met- Work on local IRB submissions- Review and customization if ICFs- Collect and review essential regulatory documents needed for site activation- Identify and escalate issues before they become critical- Adjust quickly to the changes of a dynamic organization- Update systems in a timely and accurate way- Be highly organized in an environment with shifting priorities- Analyse data and metrics relating to the site activation pathway- Learn and utilize various reporting tool

Your profile- Minimum of 4 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities.- Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements.- Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously.- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.

LI-AB2

What 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 maximize 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
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our

careers site

to read more about the benefits ICON offers.

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