Oncology Clinical Trial Manager - Global, Hands-On Lead

Planet Pharma; Watertown (MA); On-site; USD 120,000 - 180,000; 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.

The role reports to the Director of Clinical Operations and requires managing CROs, vendors, and sites, with a strong focus on on-time, on-budget delivery and regulatory compliance. Travel up to 20% is expected.

Qualifications

• Bachelor’s degree in Life Sciences; 3+ years of clinical trial management experience.
• Proven CRO and vendor management experience, including oversight of performance and budget management.
• Ability to lead trials independently in a fast-paced team environment.
• Knowledge of data management, biostatistics, and pharmacovigilance.
• Global multi-country trial experience from start-up through close-out.
• Thorough understanding of FDA regulations and ICH GCP guidelines.
• Proficiency with clinical trial systems (EDC, CTMS, TMF) and regulatory documentation.
• On-site monitoring experience preferred.
• Excellent communication and cross-functional collaboration skills.
• Highly organized with strong problem-solving and prioritization.

Responsibilities

• Provide strategic leadership and hands-on oversight of early-stage oncology trials from start-up to close-out.
• Identify risks, plan mitigations, and escalate as needed with cross-functional teams.
• Manage CROs and vendors, including oversight plans and monitoring report reviews.
• Forecast budgets, review invoices, and track trial expenses.
• Monitor enrollment, data review, sample handling, and adherence to timelines.
• Guide sites to ensure proper interpretation and execution of trial protocols.
• Contribute to development and review of trial documents and regulatory filings.
• Ensure TMF completeness and inspection readiness, internal or outsourced.
• Develop and refine departmental SOPs, processes, and best practices.

Skills

CRO management

Vendor management

Trial leadership

FDA/ICH GCP knowledge

EDC/CTMS/TMF

Global trials

On-site monitoring

Communication

Organization

Education

Bachelor’s degree in Life Sciences or related field

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.

The role reports to the Director of Clinical Operations and requires managing CROs, vendors, and sites, with a strong focus on on-time, on-budget delivery and regulatory compliance. Travel up to 20% is expected.