Description

You will manage the operational execution of clinical studies from concept through completion, ensuring compliance with regulatory requirements and study protocols. You will oversee site management, monitoring, vendor coordination, and document management while collaborating with cross-functional teams.

Requirements

• BA/BS degree in life sciences or related field, or equivalent
• Minimum of 4 years experience working on clinical studies in academic, biopharma, diagnostics, or medical device fields
• Experience with clinical EDC systems
• Familiarity with Trial Master File (TMF) organization and structure
• Competency in SOPs, ICH-GCP, and FDA Regulations

Responsibilities

• Provide high level logistical support for clinical study operations including start-up, supplies, site qualification, initiation, management, monitoring, and close-out
• Develop study-related documents such as protocols, informed consent forms, training materials, and monitoring plans
• Manage contracting, budget, invoicing, and payment processes for vendors and investigative sites
• Oversee clinical trial supplies for biospecimen collection, processing, shipment, and storage
• Monitor clinical trial progress, identify protocol deviations, and provide status updates to stakeholders