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.
• Knowledge of various projects and implementation strategies.

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.

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.

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.

Work Standards: Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations. Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned. Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu .

The expected pay range for this position is $86,248 to $100,158 per annum.

Stanford University provides pay ranges representing its good faith estimate of the salary or hourly wage the university reasonably expects to pay for a position upon hire. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.

Specifics about the rewards package for this position may be discussed during the hiring process.

Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources by submitting a contact form .

Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.