Clinical Trials Manager, Early Phase Oncology (Office Based)

Job Description

We are seeking a Clinical Trials Manager (CTM) to support the Early Phase Oncology pipeline. The CTM drives end-to-end operational delivery of early-phase oncology trials, ensuring high-quality execution through strong cross-functional leadership and CRO/vendor oversight. This role serves as a key contributor for study execution and study management by coordinating with the internal teams and external partners (including CROs and vendors), and ensuring alignment across all stakeholders to achieve study objectives. The CTM applies strong project management, clinical, and regulatory expertise to proactively identify risks, implement solutions, and maintains study timelines to meet the study deliverables for the in-house and/or hybrid model clinical trials.

This is one of three office-based positions located in Foster City, CA or Parsippany, NJ

Prior CRO/Pharma experience REQUIRED.

Prior Oncology experience REQUIRED.

Early Development/Early Phase Oncology experience preferred but not REQUIRED.

Key Responsibilities:

• Coordinating and supervising all aspects of clinical study.
• Assists Clinical Program Manager in the overall study management.
• Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports.
• Maintains study timelines.
• Contributes to development of study budget.
• Contributes to development of RFPs and participate in selection of CROs/vendors.
• Manage CROs/vendors.
• Coordinates review of data listings and preparation of interim/final clinical study reports.
• May contribute to development of abstracts, presentations, and manuscripts.
• Ensures effectiveness of site budget/contract process.
• May be asked to train CROs, vendors, investigators, and study coordinators on study requirements.
• Assists in determining the activities to support a project’s priorities within functional area.
• Under supervision, they may design scientific communications within the company.
• Travel is required.
• Excellent teamwork, communication, decision-making and organizational skills are required.
• Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
• Must be able to generally understand, interpret, and explain protocol requirements to others.
• Must be able to prioritize multiple tasks.
• May serve as a resource for others within the company for clinical trials management expertise.
• Under general supervision, is able to examine functional issues from an organizational perspective.
• Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision.
• Must have general, functional expertise to support SOP development and implementation.

Basic Qualifications:

• Bachelor's Degree and Five Years’ Experience in a relevant scientific discipline. OR
• Masters' Degree and Three Years’ Experience in a relevant scientific discipline.