Senior Start Up Associate – Freelance
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Job Description
Freelance Senior Start Up Associate managing clinical-trial start-up submissions in Greece under CTR via CTIS. Supporting site activation, regulatory communications, contracts, translations, and trial documentation.
Responsibilities:
- Perform and manage start-up activities for assigned studies at country and site levels
- Prepare, submit, and track initial applications and amendments to Competent Authorities and Ethics Committees (CA/CEC/LEC), IRBs, and other applicable bodies
- Manage official communication with authorities and ethics committees; prepare response submission packages for authority queries
- Advise study teams on local legislation and import/export requirements from a submission perspective
- Adapt trial materials, including ICFs, labels, and patient documents, to local country requirements
- Compile IP release and essential document packages to ensure timely site activation
- Support contract negotiations (CTAs) with sites/institutions
- Manage translation requests and review translations of local-language trial documentation required for submissions
- Update study management databases and file trial correspondence in the TMF according to SOPs and study plans
- Maintain ongoing status updates with study teams, sites, and the study PM team
Requirements:
- Bachelor’s degree in Life Sciences, Nursing, or related field
- Fluent English language
- Minimum 2-3 years of recent actual experience with Start up activities in Greece managing submission under CTR via CTIS
- Strong knowledge in clinical research regulatory requirements at country and global levels as per GCP
- Experienced user of Microsoft Office Suite
- Attention to detail and time-management skills
- Team work and collaboration within study teams as well as Clients/vendors as applicable
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