Study Start-up Lead

ICON plc • Raleigh, NC

2d

About The Position

Start-Up Manager 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 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

Responsibilities

• 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 enrol, 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed