Site Specialist

Description

• Supporting Study Start-Up activities, including review of essential documents, green light process management, and site activation readiness.
• Handling maintenance tasks such as customization of site-specific Informed Consent Forms (ICFs), coordination of translations, EC/IRB submissions, and documentation in eTMF systems.
• Assisting in the contract process, including understanding site contract workflows, managing contract amendments, participating in negotiations, and ensuring finalization of executed agreements.
• Collaborating effectively with cross-functional teams and stakeholders to ensure timelines are met and compliance is maintained.
• Communicating clearly and confidently with both internal and external teams, demonstrating excellent written and verbal communication skills.
• Working flexible hours to support global operations.

Qualifications

• Bachelor’s degree in life sciences, business, or a related field.
• 3+ years of experience and solid understanding of study start-up processes, maintenance activities, and contract management in clinical trials.
• Strong organizational skills and the ability to manage multiple priorities with attention to detail.
• Excellent communication skills—both written and verbal—with the ability to liaise effectively across global teams.
• Familiarity with ICF customization, translation workflows, IRB/EC submission processes, and contract negotiations is highly desirable.
• Willingness to work flexible shifts to align with global team needs.