Sr Clinical Trial Manager

Position Summary

The Senior Clinical Trial Manager is responsible for the day-to-day operational oversight of one or more clinical trials across all regulatory phases, including trial start-up, execution, and close-out. This individual ensures that all activities are carried out in alignment with the clinical protocol, Good Clinical Practice (GCP), applicable regulations, and internal standard operating procedures (SOPs). The role includes direct management of external partners such as Contract Research Organizations (CROs) and specialized vendors. This position can be fully remote, with occasional travel for meetings and trial-related activities.

Key Responsibilities

• Manage clinical operations for at least one trial across its full lifecycle

• Oversee all aspects of trial management, including:

  • Study timeline planning and execution

  • Clinical budget creation and oversight

  • Reporting of key study metrics to leadership

• Lead internal, cross-functional study teams including scheduling, conducting meetings, and ensuring timely documentation

• Manage and oversee CROs and vendors involved in study execution

• Contribute to and participate in key study meetings (e.g., vendor selection, kick-offs, investigator meetings)

• Ensure investigators and study site staff receive required training and that documentation is complete

• Review and approve monitoring visit reports, escalating risks as per study escalation plans

• Evaluate CRO performance using Key Performance Indicators (KPIs) and develop mitigation plans as needed

• Provide input into the development of study documents including monitoring and communication plans

• May contribute to or lead process improvement initiatives within clinical operations

• Mentor junior clinical staff when applicable

• Participate in on-site visits (qualification, initiation, interim, and close-out)

• Domestic travel up to 20%; international travel as required

• Maintain compliance with all applicable guidelines including ICH, FDA regulations, and internal SOPs

Qualifications

• Bachelor’s degree in a related field (life sciences, nursing, pharmacy); advanced degree preferred

• Minimum of 6 years of relevant experience in clinical research, with at least 3 years in a clinical trial management capacity

• Experience with Phase 2 and 3 trials required; oncology or rare disease (pediatric and/or adult) highly preferred

• Proven experience managing CROs and external vendors

• Previous experience as a Clinical Research Associate (CRA) is a plus

• Strong understanding of clinical trial methodologies and cross-functional collaboration

• Experience developing trial management tools and plans (e.g., site monitoring plans, communication frameworks)

• Familiarity with CRF design, IRT systems, and clinical supply chain coordination

• Deep knowledge of GCP and regulatory compliance for global trials

• Strong problem-solving, communication, and organizational skills

• Comfortable with MS Office and project management tools such as MS Project

• Detail-oriented and capable of managing complex tasks independently or collaboratively

• Able to work under tight timelines and manage competing priorities

• Builds strong working relationships with both internal and external stakeholders