Senior Clinical Trial Manager

Role Summary

Senior Clinical Trial Manager (CTM) responsible for the day-to-day study management and successful delivery of clinical trials, including budget and timeline oversight to advance therapy to patients.

Responsibilities

• Oversees scope, quality, timelines, and budget with internal functional leads, CRO, and vendors to ensure overall project objectives are met.
• Take a leadership role in the assigned study management activities.
• Provide study-specific training and leadership to clinical research staff.
• Anticipates obstacles or complex issues at the site, vendor, and study levels and implements solutions to achieve project goals or to overcome identified obstacles.
• Proactively identify issues for escalation, participate in problem-solving and implementation of risk mitigation.
• Lead other study activities as needed (e.g., site selection, start-up, recruitment, protocol deviation and TMF review).
• Develop and ensure compliance with clinical monitoring plan; conducts or oversees co-monitor as needed for staff training and QA purposes.
• Review the quality and integrity of the clinical data through review of electronic CRF data.

Qualifications

• Required: BA/BS in science-related field with 8+ years’ relevant work experience in oncology trials, with prior experience as a study lead.
• Required: Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and regulatory requirements.
• Required: Exceptional project management skills, organization, and problem-solving skills.
• Required: Eager to learn with a collaborative, team-oriented mindset.
• Required: Excellent written and verbal communication skills with an ability to express complex ideas to study personnel at research and clinical institutions.

Skills

• Project management
• Clinical trial oversight
• Cross-functional collaboration
• Regulatory knowledge
• Data review and QA

Education

• BA/BS in a science-related field.