Description
Syneos Health is seeking a temporary Site Activation Specialist to join their team in The Netherlands.
The successful candidate will be responsible for quality deliverables at the country level, ensuring compliance with project requirements and country rules.
Key responsibilities include:
- Managing site activation end-to-end process at country/site level
- Preparing and submitting regulatory authority applications, EC applications, and other local regulatory authorities or hospital approval submissions
- Ensuring local country regulatory intelligence is maintained
- Providing support for data protection at the country level
- Collaborating with investigational sites and functional leads
- Supporting continuous improvement of quality in Site Start-Up components
Requirements:
- Bachelor's degree
- Detailed understanding of clinical trial process across Phases II-IV and ICH GCP
- Ability to understand clinical protocols and associated study specifications
- Strong organizational skills with ability to handle multiple tasks effectively
- Strong written and verbal communication and interpersonal skills
- Demonstrated ability to work independently as well as part of a team
The ideal candidate will have experience working in a similar role, with a strong understanding of clinical trial start-up processes and regulatory requirements.
Syneos Health offers a dynamic and supportive work environment, with opportunities for career development and growth.