Remote Global Phase III Clinical Trial Lead – Pulmonary

Axiom Path, Inc.; Bridgewater (MA); Remoto; USD 120.000 - 160.000; Tempo pieno

Descrizione del lavoro

Axiom Path is seeking a Senior Clinical Trial Manager to lead complex global trials in pulmonary indications. This role is remote within the United States and will coordinate cross-functional teams, sites, and CROs to ensure study success.

The candidate brings hands-on startup experience and deep knowledge of ICH-GCP, eTMF, and trial systems. The position is a long-term contract through October 2028, offering exposure to international teams and cutting-edge oncology and respiratory studies.

Competenze

• Minimum 7+ years of clinical trial management experience in pharma, biotech, or CROs.
• Experience with large, international Phase III trials and pulmonary/respiratory indications is preferred.
• Hands-on startup, ICF review, IRB/EC feedback resolution, and site budget negotiations.
• Proven oversight of CROs, vendors, and outsourced activities.
• Strong Excel skills for detailed trackers and timelines.
• Familiarity with Veeva Vault eTMF and Medidata Rave systems.

Mansioni

• Coordinate multinational trials with emphasis on Phase III pulmonary studies.
• Lead startup activities: ICF reviews, IRB/EC feedback, site budgets.
• Oversee CROs and vendors to ensure timelines and quality.
• Maintain Excel-based trackers for startup progress and milestones.
• Support enrollment and ongoing study management; ensure regulatory compliance.
• Provide operational updates to study leadership and manage deliverables.

Conoscenze

Clinical trial management

Phase III trials

IRB/EC coordination

CRO oversight

Stakeholder management

Excel proficiency

eTMF systems

Formazione

Bachelor's degree in life sciences

Strumenti

Veeva Vault eTMF

Medidata Rave

Descrizione del lavoro

Axiom Path is seeking a Senior Clinical Trial Manager to lead complex global trials in pulmonary indications. This role is remote within the United States and will coordinate cross-functional teams, sites, and CROs to ensure study success.

The candidate brings hands-on startup experience and deep knowledge of ICH-GCP, eTMF, and trial systems. The position is a long-term contract through October 2028, offering exposure to international teams and cutting-edge oncology and respiratory studies.