SCI-CTO Study Start-UP Project Manager (Hybrid)

Duties

• Oversee study start-up data management for cancer clinical trials.
• Develop and manage systems to organize, collect, report, and monitor data collection.
• Extract, analyze, and interpret data.
• Develop project schedules, targets, measurements, and accountabilities, as assigned.
• Lead team meetings and prepare/approve minutes.
• Formally supervise, train, and/or mentor new staff or students, as assigned, potentially including hiring, preparing or assisting with the preparation of performance evaluations, and performing related duties, in addition to instruction on project work.
• Audit operations, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes.
• Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries.
• Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices.
• Ensure regulatory compliance.
• Regularly inspect study documents to ensure ongoing regulatory compliance.

Qualifications

• Knowledge of clinical trials data management and clinical quality management.
• Clinical knowledge in the field of Thoracic.
• Education & Experience: Bachelor's degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.
• Knowledge, Skills And Abilities: Strong interpersonal skills; proficiency with Microsoft Office and database applications; experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices; knowledge of medical terminology.
• Certifications & Licenses: Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.