Overview
In this role you support country-level Site Activation activities to ensure compliant startup and ongoing site operations. You collaborate with Site Activation Managers, the project team, and sponsors to meet timelines and maintain quality. You will manage regulatory document preparation and tracking, while applying GCP/ICH and local regulations. The position requires UK clinical trial landscape expertise and is home-based. You will drive effective cross-functional coordination to enable timely site activation and project success.
Responsibilities
- Act as Single Point of Contact for investigative sites, SAMs, project teams, and other departments
- Ensure SOP/WIs adherence and on-time delivery of project milestones
- Perform start-up and site activation activities per regulations and work instructions
- Distribute completed documents to sites and internal teams
- Prepare and verify site regulatory documents for completeness and accuracy
- Maintain internal systems and tracking tools with project-specific data
- Review site performance metrics and provide management feedback
- Plan and track project timelines and contingencies
- Oversee regulatory and contractual document progression (ICF, IP release, etc.) within timelines
- Offer local regulatory expertise to SAMs during planning and execution
- Quality control documents received from sites
- May liaise with sponsors on certain initiatives
Key requirements
- Bachelor’s Degree in life sciences or a related field
- 3 years clinical research experience
- In-depth knowledge of clinical systems, procedures, and corporate standards
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
- Knowledge of local regulatory requirements, SOPs and corporate standards
- Understanding of the regulated clinical trial environment and drug development process
- Effective communication
- Attention to detail
- Strong organizational skills
- GCP/ICH regulatory knowledge
- Regulatory documentation management
- Clinical trial start-up processes
Study Start Up Specialist - UK IQVIA Biotech employer: IQVIA
At IQVIA, we pride ourselves on being an exceptional employer, offering a dynamic work culture that prioritises innovation and employee well-being. Our South West England location provides flexible working arrangements, comprehensive well-being support, and robust career development opportunities through our AI-powered talent marketplace, ensuring that you can thrive both personally and professionally while contributing to meaningful advancements in healthcare.
