Study Start-Up Lead: Clinical Trials Expert

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

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