Study Start-up Lead

ICON Clinical Research; Durham (NC); On-site; USD 110,000 - 150,000; Full time

Job summary

ICON Strategic Solutions is seeking a Study Start-Up Lead to manage country-level start-up activities in alignment with ICH-GCP and local regulations. You will prepare regulatory documentation, track submissions, and report site performance, collaborating with CRAs and the Local Study Team to hit milestones.

The role requires strong project management, excellent communication, and the ability to work under tight deadlines across multiple sites, with responsibility for eTMF and CTMS data

Qualifications

• Bachelor’s Degree, preferably in life sciences.
• Minimum of 5 years of experience in a Clinical Research environment, focusing on Start-Up.
• Strong project management skills, with a deep understanding of regulatory and submission processes
• Excellent written and verbal communication abilities.
• Proven ability to work efficiently to tight deadlines and manage multiple priorities.

Responsibilities

• Lead start-up activities at country level in compliance with ICH-GCP and regulations.
• Prepare and manage country/site regulatory documentation and submissions.
• Collaborate with CRAs and Local Study Team to meet start-up milestones.
• Update CTMS and report site performance metrics.
• Ensure essential documents are uploaded to eTMF per ICH-GCP and SOPs.
• Provide regular updates to Line Managers on milestones.

Skills

Project management

Regulatory submission

Communication skills

Time management

Clinical Research experience

Education

Bachelor’s degree in life sciences

Tools

CTMS

eTMF

Job description

Study Start-Up Lead

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

What you will be doing

• The Study Start-up/Site Activation Lead is responsible at country level for managing and conducting start-up activities in compliance with the client procedures, documents, local and international guidelines such as ICH – GCP and relevant regulations.

• The Study Start-up/Site Activation Lead will prepare, review, track and manage site regulatory documentation at country and site level, and will maintain, review and report on site performance metrics.

• The Study Start-up/Site Activation Lead works in close collaboration with the CRAs and the Local Study Team/Local Study Associate Director to ensure that study start-up activities and milestones are achieved in a timely and efficient manner

• Typical Accountabilities:

• Contribute to ensure that clinical and operational feasibility assessment of potential studies is performed to the highest quality.

• Accountable for study start-up and regulatory maintenance being in charge with collection, preparation, review and tracking of documents for the application process;

• Accountable for submission of proper application/documents to Regulatory Authorities and/or IEC/IRB during start-up period.

• Actively participates in Local Study Team (LST) meetings.

• Update CTMS and other systems with data from study sites as per required timelines during the start-up period.

• Follow up on outstanding actions with study sites during start-up period to ensure resolution in a timely manner.

• Ensure timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, client SOPs and local requirements. Support QC checks performed by Trial Manager or delegate to ensure that all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enroll, and in line with client SOPs.

• Provide regular information to Line Managers at country level on study and planned study milestones/key issues during the start-up period.

Your profile

• Bachelor’s Degree, preferably in life sciences.

• Minimum of 5 years of experience in a Clinical Research environment, focusing on Start-Up.

• Strong project management skills, with a deep understanding of regulatory and submission processes

• Excellent written and verbal communication abilities.

• Proven ability to work efficiently to tight deadlines and manage multiple priorities.

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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

Visit our careers site (https://careers.iconplc.com/benefits) to read more about the benefits ICON offers.

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.