Description
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a Site Specialist II, you will support preparation, process and tracking of site level critical documents and/or of site activation tasks required for site activation in accordance with ICON SOPs/WPs, Sponsor SOPs, applicable regulations/guidelines and the principles of ICH/GCP.
Responsibilities
- Recognize, exemplify and adhere to ICON’s values of Accountability and Delivery, Collaboration, Partnership and Integrity
- Support Site Partners to collect, review, organize and assemble initial start-up and maintenance submission packages to Central EC/IRB, Local EC/IRB, Competent Authorities
- Support collection and assembling of all documents needed in the Critical Document Package (CDP) and/or those required for site activation
- Perform timely and accurate progress data entry of all documents collected from sites and of the relevant study site activation activities into the appropriate tracking systems and tools
- Participate to internal study review meetings with study teams to provide updates on site progress in document collection and on the executed site activation tasks
- Accurately forecast Site Activation plans and ensure that they are reflected accurately in ICON’s systems
- Ensure accuracy and timely completeness of Trial Master File (TMF) documents submitted during start-up and perform a Quality Control (QC) review of files before transfer to maintenance for filing in TMF
- Attend study team meetings as required
- Other duties as assigned
Requirements
- Bachelor's degree in life sciences or a related field
- Very good knowledge of English as well as the local language
- Minimum of 2 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
Rewards & Benefits
- 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