Study Start-Up Project Manager - Hybrid

The Stanford Cancer Institute (SCI) is one of an elite number of National Cancer Institute-Designated Comprehensive Cancer Centers in the country, and is a prominent, dynamic, growing and complex Institute within the Stanford University School of Medicine. The SCI actively works to build synergies and collaborations among faculty with cancer-relevant expertise from four Schools and over 30 departments across Stanford University. We seek a Study Start-Up Project Manager to help us enact our mission to reduce cancer mortality through comprehensive programs of cancer research, treatment, education and outreach. Given the SCI's mission, breadth, and depth, it employs over 320 staff members in a fast-paced, team-oriented, and forward-thinking environment with tremendous opportunities for personal and professional growth. The Clinical Trials Office (CTO) is an integral component of the Stanford Cancer Institute since the vital work performed there enables our adult and pediatric cancer centers to translate research from the laboratory into the clinical setting. You will be working with an unparalleled leading edge community of faculty and staff who are fundamentally changing the world of health care in the cancer arena.

Reporting to The Clinical Research Manager of study start-up, the Study Start-Up Project Manager will be conversant in the goals, mission and priorities of the Institute, and utilize this knowledge to conduct industry sponsored trials, cooperative group trials, investigator initiated clinical research studies, from start up to close out. We are seeking candidates with excellent organizational skills, attention to detail, and outstanding oral/written communication skills with the ability to work with multi-disciplinary teams. Our staff run toward challenges, and you will have a demonstrated history of doing the same with a high degree of professionalism, initiative and flexibility.

Duties include*:

• 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 document to ensure ongoing regulatory compliance.
• Hybrid work agreement.

* - Other duties may also be assigned.

DESIRED 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.

EDUCATION & EXPERIENCE (REQUIRED):

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 (REQUIRED):

• 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.

PHYSICAL REQUIREMENTS*:

• Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.
• Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
• Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.

* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.

WORKING CONDITIONS:

• Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections.
• May require extended or unusual work hours based on research requirements and business needs.