Hybrid Clinical Trials Manager – Oncology & I&I

Monte Rosa Therapeutics, Inc.

Boston (MA)

Ibrido

USD 150.000 - 190.000

Tempo pieno

11 giorni fa

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Descrizione del lavoro

Monte Rosa Therapeutics, Inc. is seeking a highly experienced Clinical Trials Manager with oncology/I&I expertise to lead planning, execution, and delivery of global clinical trials from First in Human through Phase III.

Reporting to Head of Clinical Operations, this role oversees study budgets, timelines, CRO/vendor management, and cross-functional collaboration while ensuring ICH/GCP compliance and high ethical standards.

Competenze

Bachelor’s degree in health sciences or related field.
Minimum 8–10 years of global clinical trial and program operations experience.
Experience with developing operations strategy, site monitoring, risk mitigation, and CRO/vendor oversight.
FDA regulations, ICH/GCP knowledge and practical application.

Mansioni

Delivery of clinical program budgets, timelines, and resources with quality focus.
Collaborate on strategy for oncology and non-oncology indications.
Represent Clinical Operations at cross-functional program meetings.
Lead and oversee execution of trials to meet timelines, budget, and quality standards.
Manage CROs/vendors and ensure adherence to ICH/GCP and study timelines.
Develop and execute Clinical Trial Operations Strategy and oversight plans.
Lead CRO/vendor selection and RFP processes.
Track trial budgets and provide forecasting to finance.
Provide oversight of CROs and vendors for quality and compliance.
Contribute to clinical documents and regulatory submissions.
Establish study timelines and monitor metrics.
Mentor junior team members.
Define KPIs and identify process improvements.