Freelance Study Start Up Specialist
- Experience Level
- Experienced (non-manager)
Upsilon Global have partnered with a Small Dutch CRO, who are looking for a Freelance SSU Specialist, to begin on the 1st July with a 0.15-0.20 FTE availability, for a Duration of 4-6 months
Our partner is run by two professional's expertise with more than 30 years of global experience.
They have a high-performance team, with 95% more contractors placed in the current years, this is because they provide excellent training that can open up new opportunities. Our partners focus on phase I/II studies and specialise in rare diseases who work with small biotech firms.
They are currently operating in 25 countries and have managed to conduct over 500 clinical trials overall. Each year they manage to submit 750 regulatory submissions.
This is a study start up role, for a new study in Celiac disease, phase 1 (gastroenterology). The gastroenterology experience is not a specific requirement, however SSU experience is.
These are the activities you must have se sort of experience within :
- Support with feasibility (i.e. following up with sites)
- Conducting Pre-study visits
- Submissions to Competent Authority and Ethic Committees
- Collecting site documents and arranging site approvals
- Create country specific ICF based on Master ICF
- Negotiation of the Investigator Agreements (getting site feedback and negotiation of the budget; Legal language will be negotiated in close collaboration with our Legal department. Contractor does not need to have legal background)