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.