Freelance Study Manager (6 - 12 month contract)
TFS, South Korea

TFS is a Global CRO headquartered in Sweden. We genuinely believe that "Global in mind and local at heart" is the core of our success; we operate in a global environment while retaining an in depth knowledge of regulatory requirements in every county where we operate. At TFS, you will be offered the possibility to develop in a global organization wit a company culture distinguished by passion, innovation and talent.

The Study 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: logistics (provision of study materials and documents, access 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 activities.
• In charge of site-level reporting (internally and externally)

Requirements

• Scientific background is highly recommended
• Excellent knowledge of clinical research standards
• Knowledge of local regulations and regulatory processes related to study start-up phase.
• Experience in clinical research activities including relevant experience in site activation (e.g. monitoring)
• Ability to integrate into an international team and efficiently interreact with colleagues
• Excellent organizational skills are required to supervise parallel projects

Job Rewards and Benefits