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Clinical Project Manager - Remote

Posted 1 week ago
Project Management
Full Time
USA

Overview

The Clinical Project Manager is responsible for supporting clinical operations for Glycomine's programs, ensuring the execution of clinical trials from start to finish while collaborating with various stakeholders.

In Short

  • Manage clinical operations for multiple studies and indications.
  • Collaborate with vendors and clinical sites for trial execution.
  • Ensure compliance with regulatory requirements and quality standards.
  • Oversee day-to-day operations and manage outside CROs.
  • Prepare and review study documents and feasibility reports.
  • Analyze clinical trial data for accuracy and integrity.
  • Support the planning and implementation of clinical studies.
  • Forge strong relationships with investigators and site staff.
  • Contribute to operational risk management strategies.
  • Maintain clinical and regulatory files throughout trial conduct.

Requirements

  • BA/BS in a health-related field; MA/MS preferred.
  • 5+ years of experience in clinical operations in biotech/pharmaceuticals.
  • Strong experience managing relationships with CROs.
  • Proven track record in managing clinical trials.
  • Expertise in drug development and early-stage clinical trials.
  • Strong project and vendor management skills.
  • Ability to manage multiple priorities and adapt to changes.
  • Experience with global studies required.
  • Knowledge of GCP/ICH regulations is essential.
  • Willingness to travel up to 25% for the role.

Benefits

  • Work in a dedicated team focused on rare diseases.
  • Opportunity to contribute to meaningful medical advancements.
  • Flexible work environment with remote options.
  • Collaborative culture with diverse expertise.
  • Professional development opportunities within the clinical field.
Glycomine logo

Glycomine

Glycomine is a small clinical-stage biotechnology company dedicated to developing therapeutics for congenital disorders of glycosylation (CDG), which are serious rare diseases that currently lack disease-modifying treatment options. The company focuses on addressing the unmet medical needs of patients and families affected by these conditions, leveraging a multidisciplinary team with diverse expertise. Glycomine's lead clinical program targets PMM2-CDG, aiming to provide innovative solutions that can significantly enhance the quality of life for those impacted by rare diseases.

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