Clinical Trial Manager - Remote

Overview

The Clinical Trial Manager is responsible for the execution and management of assigned clinical studies while ensuring GCP Compliance, high study quality and timely completion. This position is responsible for meeting functional, organizational, and corporate goals by successfully managing clinical trials.

In Short

• Lead one or more regions or clinical studies from concept to protocol.
• Manage external vendors and Contract Research Organizations (CROs).
• Oversee CRO clinical monitoring activities at clinical sites.
• Assist with site feasibility, site selection, and country/site-start-up activities.
• Prepare, review, and approve study documents.
• Assist with protocol development and study report completion.
• Review study and site budgets and vendor/CRO invoices.
• Participate in Investigator Meetings.
• Ensure Trial Master File is current and maintained.
• Assist and support data query process.

Requirements

• Bachelor’s degree in a scientific discipline or equivalent is required.
• At least 5 years of biopharma industry experience with clinical trials.
• Must have vendor management experience in clinical operations.
• Global trial, pediatric, orphan drug, and/or rare disease knowledge preferred.
• Knowledge of clinical trial documentation and regulatory requirements.
• Strong verbal and written communication skills.
• Ability to build and maintain strong working relationships.
• Demonstrates skills in negotiation, multi-tasking, organization, and decision making.
• Proactively identifies problems and generates possible solutions.
• Structured and organized with excellent attention to detail.

Benefits

• Patient Days to hear directly from individuals living with conditions.
• A culture inspired by values: put patients first, think independently.
• A decentralized model that enables focus on advancing science.
• A collaborative, fast-paced, data-driven environment.
• Access to learning and development resources.
• Robust and market-competitive compensation & benefits package.
• Flexible PTO.
• Rapid career advancement for strong performers.
• Commitment to Diversity, Equity & Inclusion.