This position is responsible for:
- Certifying sites selected for a trial based on the study-defined criteria.
- Activating sites he/she is responsible for, according to agreed timelines and quality standards.
The Start-Up Manager performs any/all of the following tasks and responsibilities, as well as any other tasks deemed appropriate by the Supervisor:
- Implementation of site identification and selection activities.
- Confirmation that all tasks required for activating a site are completed according to agreed standards, including but not limited to:
- Logistic aspects (e.g. provision of study materials and documents, accesses to systems)
- Compilation of documents required for activation (e.g. Site Activation Package).
- Approval of country/site level informed consents prior to submissions
- Contract and Budget negotiation
- Site training requirements
- Responsible for the coordination (and information) of site activation activities until transfer to PM with all parties (including site, monitoring, QARA, CSU, PM, all other appropriate team members) to ensure site activation timelines are met. He/ she is responsible to detect and escalate country or site level issues that could impact site activation timelines
- In charge of site-level reporting (internally and externally) In cases of limited resource needs for a study, the Start-Up Manager may play the role of Study Lead (without supervisor duties).
Education and Training:
- Scientific background is highly recommended
- Excellent knowledge of clinical research standards (incl. ICH-GCP)
Experience & Key Competencies:
- > 1 years of experience in clinical research activities including relevant experience in site activation (e.g. monitoring)
- Ability to integrate to an international team and efficiently interact with colleagues
- Excellent organizational skills are required to supervise multiple parallel projects
- Computer literacy
- Fluent English
- Competitive rate (Daily/hourly)
- 6months contract (Can be extended)
- Working on challenging project