Study Startup Specialist II

We are looking for a motivated clinical research professional to join our team and support the successful start-up of clinical studies in this role you will work closely with project teams and investigational sites coordinating activities from site contracts and regulatory documentation through to site activation. This is a great opportunity for someone with clinical start-up experience who enjoys working across multiple stakeholders taking ownership of timelines and helping studies move efficiently from planning to execution.

You will: 

• Maintains study-specific and corporate startup tracking systems
• Facilitates site budgets and contract negotiations
• Supports site regulatory document collection
• Under supervision may prepare initial submission dossiers to competent authorities ethics committees and/or site submission dossiers (as applicable)
• Communicates with the project team and investigational sites throughout the study startup phase
• Develops site specific startup timelines and enrollment projections and is responsible for meeting the site activation milestones
• May review study specific translations
• Supervises Trial Master File (TMF) maintenance throughout the study startup phase

Qualifications :

• College/University degree in Life Sciences or an equivalent combination of education training and experience
• 2-3 years prior clinical study and site startup experience
• Well-developed communication and organizational skills
• Ability to negotiate and build relationships at all levels
• Leadership mentoring and organizational skills

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.

Remote Work :

No

Employment Type :

Full-time