Senior Clinical Trial Manager - Oncology Operations Lead

Aktis Oncology; Boston (MA); On-site; USD 110,000 - 170,000; Full time

Job summary

Aktis Oncology is seeking a Senior Clinical Trial Manager to lead trials from start-up through database lock. You will coordinate protocol development, CRFs, and study plans while ensuring timelines, budgets, and data quality across sites and CROs.

The role requires strong ICH-GCP knowledge, oncology experience, and the ability to manage global teams in a virtual or mixed setting. Travel up to 10–20% is expected.

Qualifications

• BS in Life Sciences or equivalent.
• Minimum 3–5 years of clinical trial management in pharma/biotech/CRO; oncology experience preferred.
• Experience managing trials from start-up to database lock is required.
• Strong knowledge of ICH-GCP guidelines and global study operations.

Responsibilities

• Leads and manages clinical trials from startup to database lock.
• Authors and reviews study protocols, CRFs, IBs, consent forms, and study plans.
• Monitors timelines, budgets, and quality; mitigates risks.
• Oversees CROs and vendors and ensures site management and data quality.
• Communicates effectively with study teams and stakeholders.

Skills

Clinical trial management

Budget management

Vendor management

Cross-functional collaboration

Project planning

Education

B.S. degree in Life Sciences

Tools

CTMS (Clinical Trial Management System)

Data capture tools

Job description

Aktis Oncology is seeking a Senior Clinical Trial Manager to lead trials from start-up through database lock. You will coordinate protocol development, CRFs, and study plans while ensuring timelines, budgets, and data quality across sites and CROs.

The role requires strong ICH-GCP knowledge, oncology experience, and the ability to manage global teams in a virtual or mixed setting. Travel up to 10–20% is expected.