Early-Phase Oncology Trial Lead

Planet Pharma; Cambridge (MA); On-site; USD 120,000 - 160,000; Full time

Job summary

Planet Pharma is seeking an experienced Clinical Trial Manager to provide strategic leadership and hands-on oversight of early-stage oncology trials, including first-in-human studies. You will lead cross-functional teams, CROs, and vendors to ensure trials are delivered on time, on budget, and in full regulatory compliance.

The role requires 3+ years of trial management, strong regulatory knowledge, and the ability to manage multi-country trials from start-up to close-out in a fast-paced

Qualifications

• 3+ years of clinical trial management experience.
• Proven CRO and vendor management oversight and budgeting.
• Thorough understanding of FDA regulations and ICH GCP guidelines.
• Global multi-country trial experience from start-up to close-out.
• Proficiency with trial systems (EDC/CTMS/TMF) and regulatory documentation.

Responsibilities

• Oversee all aspects of trial management from start-up through close-out.
• Identify and mitigate risks affecting budget, resources, and timelines.
• Manage outsourced activities with CROs and vendors, including oversight plans and monitoring reports.
• Forecast, review invoices, and track trial budgets and expenses.
• Ensure TMF completeness, inspection readiness, and regulatory documentation.

Skills

CRO management

Vendor management

Trial leadership

Regulatory knowledge

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in Life Sciences or related field

Advanced degree preferred

Tools

EDC

CTMS

TMF

Job description

Planet Pharma is seeking an experienced Clinical Trial Manager to provide strategic leadership and hands-on oversight of early-stage oncology trials, including first-in-human studies. You will lead cross-functional teams, CROs, and vendors to ensure trials are delivered on time, on budget, and in full regulatory compliance.

The role requires 3+ years of trial management, strong regulatory knowledge, and the ability to manage multi-country trials from start-up to close-out in a fast-paced