Start-Up Lead
At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise.
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.
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & BenefitsICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
