上海招聘

Study Start-up Function Employee Profile
Having graduated with preferably a life science degree (or comparable) ICON Study Start-up Services (SSUS) are building for a bright future. With a successful career already established in clinical research SSUS are looking to attract fellow achievers, to join a quiet revolution in the approach to activate sites. Site activation is currently one of the most challenging aspects within the project lifecycle and demands on our customers, from market forces, are requiring ICON, their key service provider, to improve their capabilities to deliver them a competitive advantage, whilst allowing ICON to differentiate themselves via best-in-class performance.
ICON have revaluated their site activation process to streamline and inject subject matter experts into the process in specialist areas, most noticeably in Legal, Submissions (Competent Authority and Ethics), Site Negotiators and Drug Release, overseen by project management experts-know as SSUS leads.
Due to the fast nature of the business SSUS works within, we're looking to develop our team to reach for new frontiers of performance and quality and to establish themselves as the go-to-person in their specialism, building upon their already acquired skills of:
· Collectively working to the end goal: the ability to focus on the objectives and to formulate decisions, attitudes and collaborative skills to realise the outcome.
· Proactively: See an opportunity, to seize the initiative, or to prevent or correct a process-"many energised hands makes light work"
· Dynamic mental agility: within SSUS many priorities exist, the ability to work to the importance and not the urgency is critical
· Win-win: naturally strive for the mutually beneficial solution, to generate and maintain strong working relationships, via trust and loyalty
· Team Player: Working in combination with your colleagues to positively achieve goals no one person could have done alone. Everyone is a master of something and not everything
· Healthy Lifestyle: The ability to sustain a long-term effective lifestyle, via balance and ability to renew energy, new information and health.
Role Responsibility
· Coordinate and lead the country Study Start Up teams for multi-country studies.
· Drive the teams' efficiency and adherence to study procedures and timelines.
· Establish regulatory requirements and site contracts to ensure a smooth start-up process.
· Liaise and coordinate with PM to facilitate consistent and coherent communication for start up.
· Be an inspiration, the lead should be the team motivator for the Study Start Up team.

In addition, your tasks will include:

· Provide regional planning, risk and status
· Oversee regulatory and ethics committee submissions, ensuring submissions timelines are met and any questions are followed up promptly
· Oversee site contracting, establishing contract templates for the study, along with fallback language and the negotiation process
· Ensure regulatory documents are collected in a timely manner, facilitating the release of investigation product to the sites as soon as recruitment is permitted

A global leading company focus on the drug research, clinical research and providing Clinincal operation solution for world famous pharamcy company. We have over 9000 people all of the World and entered into China in 2005. Will with a good development plan to broaden and improve China business scale.