Hybrid Study Start-Up Project Manager – Clinical Trials

Stanford University; Palo Alto (CA); Hybrid; USD 120,000 - 150,000; Full time

Job summary

Stanford University seeks a Study Start-up Project Manager for GI trials in a hybrid role based in Palo Alto, CA. You will lead start-up activities, coordination with investigators, sponsors and regulatory bodies to advance industry-sponsored and investigator-initiated studies.

You'll manage data, budgets, timelines and compliance, mentoring staff, and ensuring strict adherence to FDA, HIPAA and IRB requirements in a fast-paced Cancer Institute environment.

Qualifications

• Knowledge of clinical trials data management and clinical quality management.
• Clinical knowledge in the field of Thoracic.
• Knowledge of various projects and implementation strategies.

Responsibilities

• Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
• Oversee data management for research projects. 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, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions and respond to requests and questions.
• 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.
• Develop study budget with staff and principal investigator, identifying standard of care versus study procedures. Track patient and study specific milestones, and invoice sponsors according to study contract.
• Ensure regulatory compliance. Regularly inspect study documents to ensure ongoing regulatory compliance.
• Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed.

Skills

Clinical Trials Data Mgmt

Thoracic Clinical Knowledge

Implementation Strategies

Education

Bachelor's degree

Tools

Microsoft Office

Database Applications

Job description

Stanford University seeks a Study Start-up Project Manager for GI trials in a hybrid role based in Palo Alto, CA. You will lead start-up activities, coordination with investigators, sponsors and regulatory bodies to advance industry-sponsored and investigator-initiated studies.

You'll manage data, budgets, timelines and compliance, mentoring staff, and ensuring strict adherence to FDA, HIPAA and IRB requirements in a fast-paced Cancer Institute environment.