Senior Clinical Trial Manager - Oncology (Hybrid)

Oscar; Boston (MA); Hybrid; USD 140,000 - 190,000; Full time

Job summary

Oscar Associates Limited (US) is seeking an experienced Senior Clinical Trial Manager/Lead to provide strategic and operational leadership across oncology programs in Cambridge, MA.

The role partners with Clinical Development and Clinical Operations to oversee startup through closeout, manage CROs, sites, budgets, timelines, and ensure ICH-GCP compliance. Hybrid work arrangement with onsite at least once per week, within a fast-paced biotech environment.

Qualifications

• Minimum of 6 years of Clinical Operations experience within pharma/biotech
• At least 2 years of experience leading cross-functional clinical study teams
• Direct experience supporting oncology clinical trials, with emphasis on early-phase development
• Demonstrated expertise in clinical trial execution, site startup, CRO oversight, and vendor management
• Experience managing timelines, budgets, operational plans, and study deliverables
• Strong understanding of ICH-GCP guidelines, EU regulatory requirements, and inspection readiness

Responsibilities

• Lead Clinical Operations activities across one or more clinical-stage studies from startup to closeout
• Contribute to early- and late-phase development strategies and translate objectives into operational plans
• Develop, implement, and oversee clinical trial plans, timelines, and deliverables
• Provide operational input into study documents (synopses, protocols, ICFs, IBs, CSRs)
• Oversee CROs, sites, and external vendors to meet performance and milestones
• Lead site startup activities and coordinate internal and CRO-led initiatives

Skills

Leadership

Cross-functional collaboration

Project management

Communication

Regulatory compliance

Education

Bachelor's degree in Life Sciences, Engineering, or related technical discipline

Tools

CTMS

eTMF platforms

Job description

Senior Clinical Trial Manager / Senior Clinical Trial Lead

Location: Cambridge, MA (Hybrid - Onsite at least once per week)

Industry: Biotechnology / Pharmaceuticals

Therapeutic Area: Oncology

Focus: Early- and Late-Phase Clinical Development

Position Overview

We are seeking an experienced Senior Clinical Trial Manager / Senior Clinical Trial Lead to provide strategic and operational leadership across clinical development programs. This individual will partner closely with Clinical Development and Clinical Operations leadership to oversee the planning, execution, and management of clinical trials from study initiation through closeout.

The ideal candidate will bring extensive experience in oncology clinical development, particularly early-phase trials, along with demonstrated success managing CROs, clinical sites, external vendors, study timelines, budgets, and cross-functional teams.

Key Responsibilities

• Lead Clinical Operations activities across one or more clinical-stage studies, ensuring successful execution from startup through closeout.
• Contribute to early- and late-phase clinical development strategies, translating program objectives into actionable operational plans.
• Independently develop, implement, and oversee clinical trial plans, study timelines, and operational deliverables.
• Provide operational input into key clinical documents, including study synopses, protocols, informed consent forms (ICFs), investigator brochures (IBs), and clinical study reports (CSRs).
• Oversee CROs, investigative sites, and external clinical vendors to ensure performance expectations, contractual deliverables, and study milestones are achieved.
• Lead clinical site startup activities, coordinating both internally managed and CRO-led initiatives.
• Manage clinical studies within established timelines and budgets while proactively identifying and mitigating operational risks.
• Maintain oversight of clinical trial quality, compliance, and documentation to ensure inspection readiness.
• Oversee the implementation, integration, and ongoing management of clinical trial systems, including clinical databases, electronic trial master files (eTMF), central imaging/reading platforms, and specialty laboratory systems.
• Ensure clinical studies are conducted in accordance with ICH-GCP guidelines, applicable regulatory requirements, and internal quality standards.
• Lead cross-functional study teams, facilitating communication, accountability, and alignment across internal stakeholders and external partners.

Required Qualifications

• Minimum of 6 years of Clinical Operations experience within a pharmaceutical or biotechnology environment.
• At least 2 years of experience leading cross-functional clinical study teams.
• Direct experience supporting oncology clinical trials, with a strong emphasis on early-phase drug development.
• Demonstrated expertise in clinical trial execution, site startup, CRO oversight, and vendor management.
• Experience independently managing clinical trial timelines, budgets, operational plans, and study deliverables.
• Strong understanding of ICH-GCP guidelines, applicable EU clinical trial requirements, and regulatory compliance.
• Experience supporting clinical trial inspections and maintaining inspection-ready documentation.
• Strong leadership, project management, organizational, and communication skills.
• Ability to manage multiple priorities and collaborate effectively across multidisciplinary teams.

Preferred Qualifications

• Bachelor's degree in Life Sciences, Engineering, or a related technical discipline.
• Previous experience within a small or emerging biotechnology company.
• Prior clinical research site experience.
• Experience managing both sponsor-led and CRO-led clinical trial activities.
• Familiarity with clinical trial management systems, eTMF platforms, and other clinical data collection technologies.
• Experience contributing to clinical development strategy across multiple phases of drug development.

Ideal Candidate Profile

The ideal candidate is a hands-on Clinical Operations leader with a strong background in oncology, early-phase clinical trials, CRO/vendor oversight, and end-to-end study management.

This individual should be comfortable operating within a fast-paced biotechnology environment, independently driving clinical trial execution while maintaining close collaboration with Clinical Development leadership and external partners.

Oscar Associates Limited (US) is acting as an Employment Agency in relation to this vacancy.