Clinical Study Specialist

Overview

• Provide technical and administrative support to clinical study teams executing clinical trials.
• Assist in the execution of multiple studies across clinical programs.
• Support both internally sourced studies and those outsourced to Clinical Research Organizations (CROs).
• Contribute to a fast-growing, science-driven organization impacting patient care globally.
• Collaborate with Clinical Study Leads and Associate Managers to ensure study success.
• Hybrid work arrangement with onsite presence required four days a week.
• Engage in a six-month contract role with opportunities for professional growth.
• Utilize industry-standard tools and methodologies to support clinical trial management.

Key Responsibilities & Duties

• Organize and deliver reports and metrics to clinical study leads.
• Schedule and coordinate meetings, prepare agendas, and document minutes.
• Collate data for feasibility assessments and site selection processes.
• Review and facilitate study document approvals per standard operating procedures.
• Compile and maintain study manuals and reference materials.
• Track site activation, enrollment, and monitoring visits against plans.
• Perform reconciliations of study Trial Master File (TMF) and scheduled reporting.
• Monitor study close-out activities, including document and visit tracking.

Job Requirements

• Bachelor’s degree in Science and 2+ years of industry-related clinical experience.
• Proficiency in trial management systems and MS applications like Project, PowerPoint, Word, and Excel.
• Basic familiarity with medical terminology and clinical drug development processes.
• Strong attention to detail and ability to track and deliver study activities.
• Effective communication and interpersonal skills for internal and external collaboration.
• Resourceful problem-solving skills and proactive information assessment capabilities.
• Knowledge of ICH/GCP guidelines and clinical trial standards.
• Self-disciplined with strong time management and prioritization abilities.