Hybrid Clinical Trials Lead — Oncology & I&I

Monte Rosa Therapeutics, Inc; Boston (MA); Hybrid; USD 120,000 - 180,000; Full time

Job summary

MRTx is seeking a highly experienced Clinical Trials Manager to lead planning, implementation, and conduct of oncology and other indications across global trials. Reporting to Head of Clinical Operations, you will build operational strategies, lead trial execution from First in Human through Phase III, and mentor junior staff while ensuring compliance with ICH/GCP and SOPs.

The ideal candidate has 8–10 years of global clinical trial and program operations experience and a track record managing

Qualifications

• Bachelor's degree in health sciences or related field.
• 8–10 years of global clinical trial and program operations experience with at least 4 years of independent CTM across all phases.
• Experience with FDA regulations, ICH/GCP guidelines in clinical trials.
• Experience mentoring employees directly.
• Experience overseeing CROs, vendors, and consultants.
• Strong communications and cross-functional collaboration skills.
• Proficiency with MS Office and project management tools.

Responsibilities

• Deliver clinical programs budgets, timelines, and resources with quality focus.
• Develop and execute program strategy for oncology and non-oncology indications.
• Represent Clinical Operations in cross-functional program meetings.
• Lead trials to meet timelines, budget, and quality standards.
• Manage CROs and vendors across all trial operations.
• Develop and execute trial operations strategies and oversight plans.
• Lead CRO/vendor selection and RFP processes.
• Track trial budget and provide ongoing forecasting to finance.
• Mentor junior team members.
• Define KPIs and identify process optimization opportunities.
• Support resourcing and recruitment planning for studies.
• Ensure ethical standards and regulatory compliance.
• Represent operations to external stakeholders.

Skills

Clinical Operations

FDA/ICH-GCP knowledge

Budget & timelines management

Vendor management

Team mentoring

Cross-functional collaboration

PM tools proficiency

Education

Bachelor's degree in health sciences or related field

Tools

MS Project/Smartsheet

Excel

Word

PowerPoint

Outlook

Job description

MRTx is seeking a highly experienced Clinical Trials Manager to lead planning, implementation, and conduct of oncology and other indications across global trials. Reporting to Head of Clinical Operations, you will build operational strategies, lead trial execution from First in Human through Phase III, and mentor junior staff while ensuring compliance with ICH/GCP and SOPs.

The ideal candidate has 8–10 years of global clinical trial and program operations experience and a track record managing