Senior Oncology Clinical Trial Manager | Hybrid

BioTalent; Watertown (MA); Hybrid; USD 153,000 - 198,000; Full time

Job summary

BioTalent in Watertown, MA is seeking a Senior Clinical Trial Manager with oncology focus to lead operational execution of clinical studies. The role partners with CROs, sites, and cross-functional teams to ensure study plans, timelines, and deliverables align with ICH/GCP requirements.

Reporting to the VP of Clinical Operations, you will oversee vendor management, enrollment tracking, TMF maintenance, and study documentation, while driving risk mitigation and ensuring quality across global

Qualifications

• Bachelor’s degree or equivalent in biomedical or life sciences.
• 5-8+ years of clinical trial management experience in biotech/pharma/CRO.
• Oncology clinical trial experience required.
• Strong knowledge of ICH/GCP and global regulatory requirements.

Responsibilities

• Serve as a key Clinical Operations point of contact for the execution of clinical studies in accordance with ICH/GCP requirements, applicable regulatory guidelines, and internal SOPs/work instructions.
• Manage and oversee CROs and other clinical study vendors from initial engagement through final study deliverables.
• Lead external CRO trial management teams and ensure studies are conducted in accordance with applicable regulations, GCP, ICH guidelines, and study requirements.
• Coordinate CRO activities across functions including clinical monitoring, data management, medical monitoring, medical writing, biostatistics, and safety/pharmacovigilance.

Skills

Clinical trial management

Oncology

Vendor management

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor’s degree in biomedical, life sciences

Tools

CRO management tools

Study documentation systems

Job description

BioTalent in Watertown, MA is seeking a Senior Clinical Trial Manager with oncology focus to lead operational execution of clinical studies. The role partners with CROs, sites, and cross-functional teams to ensure study plans, timelines, and deliverables align with ICH/GCP requirements.

Reporting to the VP of Clinical Operations, you will oversee vendor management, enrollment tracking, TMF maintenance, and study documentation, while driving risk mitigation and ensuring quality across global