Clinical Trial Manager/Senior Clinical Trial Manager

Job Description

Job Description

The Clinical Trial Manager (CTM) is responsible for leading the clinical operations team to ensure the successful delivery of oncology clinical studies in alignment with protocol, timelines, budget, and quality standards. The CTM will perform job functions in accordance with ICH Good Clinical Practice (ICH GCP), FDA regulations, and LumaBridge SOPs while contributing to the organizational mission of advancing innovative oncology therapies.

Title: Clinical Trial Manager

Location: This is a home-based position.

Responsibilities:

• Author and manage the Clinical Monitoring Plan, prioritizing site recruitment, data monitoring, and other clinical deliverables to meet quality and regulatory standards.
• Manage clinical timelines, resources, and deliverables to ensure project success and Sponsor alignment
• Maintain knowledge of contract details, escalating any out-of-scope requests for review and approval.
• Review performance metrics to assess team progress and identify improvement opportunities
• Oversee setup and maintenance of the TMF and clinical trial management systems, tracking key study elements such as protocol deviations, patient status, and monitoring visit details.
• Lead site feasibility and activation processes, managing logistics for clinical supplies and tracking informed consent and other site materials.
• Manage patient enrollment, IP projections, and inventory, ensuring smooth study operations.
• Periodically review study data for potential issues in data collection or monitoring.
• Review and approve monitoring visit reports and serve as a point of escalation for CRA-related issues
• Conduct monitoring visits (PSV, SIV, IMV, COV) as needed
• Collaborate with Clinical Operations, Data Management, and Biometry teams to ensure timely data entry, query resolution, and quality data deliverables.
• Identify potential risks and establish contingency plans to ensure consistent study progress.
• Ensure quality standards and regulatory requirements are met for each study.
• Maintain TMF completeness and participate in site and study-level QC per the TMF Plan
• Communicate effectively with Sponsors, vendors, and functional team leads, selecting appropriate communication methods for clarity and efficiency.
• Present at internal and external meetings, sharing updates on risks, performance, and study status
• Develop and maintain project documents, templates, and tools.
• Participate in audit preparations and follow-up as required.
• Perform other duties as assigned

Qualifications:

Required:

• Bachelor’s degree in life sciences or related field; non-scientific degrees accepted with strong clinical research and trial management experience in CRO, pharma, or biotech.
• At least 3 years of oncology clinical trial experience; other indications considered with proven success in clinical research project management.
• Strong knowledge of clinical trial processes, ICH GCP, and FDA regulations
• Demonstrated leadership and organizational skills
• Ability to manage multiple priorities and work effectively in a fast-paced environment
• Experience with CTMS, EDC, Microsoft Office Suite, and other clinical trial software
• Excellent verbal and written communication skills
• Strong attention to detail and problem-solving ability
• Fluent in English (written and verbal)
• Ability and willingness to travel up to 15%

Preferred:

• Phase I/II oncology experience
• 2+ years of monitoring experience
• 2+ years of CTM experience at a CRO or Sponsor
• Experience mentoring CTAs or CRAs
• Understanding of clinical data workflows, interim analyses, and database lock processes