job title: Site specialist 2(icon)
7/27/20251 min read
Roles and Responsibilities
What You Will Be Doing:
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.
Your Profile:
Bachelor’s degree in life sciences, business, or a related field.
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.
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