Study Specialist II - Remote

Overview

The Study Specialist II (SS-II) plays a crucial role in overseeing site monitoring, site management, and vendor management for clinical studies, contributing to the delivery of high-quality data to support clinical development.

In Short

• Contributes to oversight of site monitoring and management.
• Supports study-related matters impacting timelines, quality, and budget.
• Develops and reviews study-specific documentation.
• Manages country and site feasibility assessments.
• Tracks regulatory document collection for participating sites.
• Facilitates investigator training materials and meetings.
• Ensures timely updates to ClinicalTrials.gov.
• Manages essential documents in the Trial Master File (TMF).
• Supports vendor management and risk identification.
• Provides administrative assistance for internal and external meetings.

Requirements

• BS or higher in nursing, life or health sciences preferred.
• Relevant industry experience may be considered in lieu of education.
• Experience in oversight of external vendors (CROs, labs, etc.).
• Proficient knowledge in study management and execution.
• Strong communication and collaboration skills.
• Ability to manage risks and resolve site-related issues.
• Experience in drug development and study design.
• Agility and proactivity in a fast-paced environment.
• Knowledge of compliance and quality standards.
• Familiarity with clinical trial processes.

Benefits

• Opportunity to work with a leading biotechnology company.
• Engagement in innovative drug development for rare diseases.
• Collaborative and empowering work environment.
• Professional growth and development opportunities.
• Comprehensive benefits package.
• Flexible work arrangements (hybrid or remote options).
• Supportive team culture focused on patient outcomes.
• Access to cutting-edge research and technology.
• Commitment to diversity and inclusion in the workplace.
• Equal opportunity employer.