Clinical Support Specialist – Regulatory & Study Start‑Up (Hybrid)

About the role

Provide operational and administrative support to clinical functions, ensuring smooth study start‑up and site activation processes in a hybrid work environment.

Key responsibilities

• Coordinate documentation and communications, manage shared mailboxes, organize project files, and track action items.
• Enter, maintain and reconcile data in project and clinical tracking systems, and monitor timelines and milestones.
• Perform document management activities including creation, formatting, version control, quality control and translation using approved vendors.
• Support Trial Master File (TMF) filing and ensure inspection‑ready documentation.
• Use AI‑enabled tools, dashboards and automated reports to provide logistical and analytical support.
• Monitor workload, budgeted effort and project hours, escalating discrepancies as needed.

Required profile

• Associate’s degree or equivalent combination of education, training and experience.
• Minimum 1 year of clinical operations experience with a solid understanding of clinical operations.
• Strong documentation and communication skills in English, with a team‑oriented approach.
• Ability to manage competing priorities in a fast‑paced environment and work both independently and collaboratively.

Required skills

• Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, Publisher).
• Ability to adopt new technologies, including AI‑enabled tools and dashboards where approved.