Study Startup Coordinator

Job Description

• Monitors startup key performance indicators for selected projects on regional/country level
• Identifies and escalates operational issues to Project Management and other functions concerned
• Cooperates with other functions to conduct training and work on process improvement pertaining to study and site startup
• Partakes in the development and update of local instructions and guidelines related to startup activities
• Provides startup support for selected projects - starting from handover to Operations until all sites are activated
• Participates in regional kick-off meetings/calls
• Provides support and technical assistance in feasibility and site identification process
• Coordinates and supports contract negotiation process
• Coordinates and supportspreparation of IP-RED packages
• Performs training of team members tailored to project needs

Qualifications

• College or University degree or an equivalent combination of education and experience that provides the individual with the required knowledge, skills, and abilities
• Minimum of 18 months industry experience in clinical research in an administrative role
• Excellent knowledge of FDA guidelines and ICH GCP
• Communication and interpersonal skills
• Attention to detail
• Ability to work in a team or independently

Additional Information

If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you. You will lead dedicated startup teams and work closely with cross-functional experts to drive your startup projects forward.