Clinical Trials Manager

About the role

This position is for an experienced Clinical Operations Professional responsible for managing Phase I-III clinical trials in an industry setting. This role emphasizes scientific rigor, collaboration, and innovative approaches in oncology clinical development.

Responsibilities

• Oversee clinical trial execution, ensuring studies are completed on time, within budget, and compliant with SOPs, FDA regulations, and GCP guidelines.
• Manage CROs and vendors, including selection, engagement, and oversight of activities such as site management, monitoring, and documentation.
• Develop and review study documentation like protocols, case report forms, and study manuals.
• Participate in team collaborations across departments, monitor study progress, and resolve issues.
• Assess investigator sites, develop monitoring plans, conduct site visits, and manage investigational product reconciliation.
• Support safety reporting, data review, and preparation of clinical reports.
• Mentor and provide guidance to Clinical Research Associates (CRAs).
• Serve as the primary clinical operations contact for internal and external stakeholders.

Qualifications

• BS or MS with at least 5 years of clinical operations experience, preferably in oncology.
• Strong knowledge of FDA regulations, ICH guidelines, and GCPs.
• Experience managing CROs and external vendors.
• Excellent communication, multitasking, and teamwork skills.
• Ability to travel (~25%).
• Preferred experience: working with global trials, cooperative group studies, investigator-sponsored trials, especially in the APAC region.

Pay

Base salary ranges from $120,000 to $150,000 USD, complemented by benefits, equity, and development opportunities.