Senior Clinical Trial Manager

Role Summary

As our Senior Clinical Trial Manager (CTM), you’ll be accountable for the day-to-day study management and successful delivery of our clinical trials. By managing all aspects of the study including budget and timeline, you’ll play a critical role in advancing our life-saving therapy through the clinic and to patients who need it most.

Responsibilities

• Oversees scope, quality, timelines, and budget with the 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 quality assurance (QA) purposes.
• Review the quality and integrity of the clinical data through review of electronic CRF data.

Qualifications

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

Education

• BA/BS in science-related field