Clinical Project Manager / Senior Clinical Project Manager at GQR in Boston, Massachusetts

Posted in Other about 15 hours ago.

Type: full-time





Job Description:

Location: Seaport MA: 2-3 Times per week!

Overview:

An innovative biopharma company specializing in rare diseases is seeking a Clinical Project Manager (CPM) / Senior CPM to provide operational leadership for clinical trials. This role includes oversight of protocols, cross-functional teams, and vendor partnerships to ensure adherence to timelines, budgets, and regulatory requirements. Ideal candidates will demonstrate critical thinking, adaptability, and leadership in managing complex clinical projects.

Key Responsibilities:
  • Lead cross-functional study teams to deliver trials on time, within scope, and budget.
  • Oversee site and vendor selection, feasibility assessments, and contract negotiations.
  • Manage study timelines, enrollment forecasts, and patient recruitment plans with risk mitigation strategies.
  • Develop and oversee monitoring and vendor management plans, including site visits and performance reviews.
  • Coordinate with internal and external teams to ensure accurate data collection, review, and submission for interim analyses and database locks.
  • Maintain and oversee the Trial Master File (TMF) in compliance with regulatory requirements.
  • Contribute to the development and review of clinical protocols, informed consents, monitoring plans, and study reports.
  • Support audits, corrective action plans, and ensure adherence to ICH/GCP guidelines and FDA regulations.
  • Mentor junior staff and participate in process improvement initiatives within Clinical Operations.

Qualifications:
  • Education: Bachelor's degree in a scientific discipline preferred (advanced degree a plus).
  • Experience: 4-7 years in clinical trial management with sponsor-side experience across various trial phases.
  • Strong knowledge of ICH/GCP guidelines and FDA regulations.
  • Experience managing vendors, CROs, and leading cross-functional teams.
  • Critical thinking and problem-solving skills with a strategic and proactive mindset.
  • Proficiency in Microsoft Word, Excel, and Project.
  • Strong interpersonal and negotiation skills with a collaborative approach.

About the Company:

This clinical-stage biopharma company is pioneering treatments for rare diseases affecting bone health and blood vessel function. Their lead program focuses on the PPi-Adenosine Pathway to address significant unmet medical needs through innovative enzyme replacement therapies.

Why Join Us?
  • Opportunity to lead impactful studies in rare disease therapeutic development.
  • Work in a collaborative, patient-focused environment.
  • Contribute to groundbreaking advancements in addressing significant health challenges.

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