Freelance Study Start-up Specialist
On-siteLisbon, Lisbon, Portugal
Job Summary
Compile and review essential document packages for site activation and serve as the primary point of contact during study start-up. Prepare and submit Central EC, Local EC, RA, and RNEC applications, including ongoing amendments and safety notifications. Support site selection for individual studies and negotiate country template contracts and budgets with investigative sites. Assist in producing site-specific contracts, manage quality control, arrange execution of CTAs, and archive documents into repositories. Execute these tasks in accordance with agreed timelines, allocated budgets, and required quality standards for clinical trials in Portugal. Submit your CV in English to apply for this as-needed freelance role.
Required Qualifications
- College/university Degree or equivalent combination of education and training
- Good understanding of clinical trial processes across Phases II-IV and ICH GCP
- Ability to interact effectively and appropriately with investigative site personnel
- Good organizational skills and good attention to detail, with proven ability to handle multiple tasks effectively
- Ability to take direction from multiple individuals and set priorities accordingly
- Ability to effectively communicate across multiple function groups (clinical team, PM, Director)
- Demonstrated ability to work independently, as well as part of a team
- Utilize problem-solving techniques effectively
- Quality-driven in all managed activities
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.