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

Stanfordlivetickets; Palo Alto (CA); Hybrid; USD 86,000 - 100,000; Full time

Benefits offered by this job

PTO days

Health benefits

Flexible work options

Tuition assistance

403(b) plan

Mental health programs

Commuter benefits

Regular full-time benefits

Job summary

Stanford Cancer Institute seeks a Study Start-Up Project Manager to oversee start-up data management for cancer clinical trials, develop schedules, lead meetings, and mentor staff.

Reporting to the Clinical Research Manager, you will ensure regulatory compliance, collaborate with investigators and sponsors, and drive process improvements in a hybrid work setting.

Qualifications

• Bachelor's degree in a related field and two years of clinical research experience.
• Strong interpersonal skills and communication.
• Proficiency with Microsoft Office and database applications.
• Experience with research protocols and regulatory or governing bodies (HIPAA/FDA, IRB).
• Knowledge of medical terminology.

Responsibilities

• Oversee study start-up data management for cancer trials and develop systems for data collection and reporting.
• Develop project schedules, targets, measurements, and accountabilities; lead team meetings and minutes.
• Supervise, train, and mentor staff, including performance evaluations and related duties.
• Audit operations to ensure regulatory compliance and lead corrective actions.
• Collaborate with investigators and sponsors; monitor and report adverse events and resolve queries.
• Provide leadership in improving policies/processes and best practices.
• Ensure regulatory compliance; inspect study documents regularly.

Skills

Interpersonal skills

MS Office

Database proficiency

Regulatory knowledge

Medical terminology

Education

Bachelor's degree in related field

2 years clinical research experience

Tools

Microsoft Office

Job description

Stanford, CA, United States (Hybrid)

Job Description

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.

Qualifications

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.

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.

At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website (https://cardinalatwork.stanford.edu/benefits-rewards) provides detailed information on Stanford's extensive range of benefits and rewards offered to employees. 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.

The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.

Benefits that support you, and your future

• 18+ PTO days per year
• Health benefits start when you start
• Flexible work options
• $6000+ annual tuition and training assistance
• 403(b) plan
• Mental health and wellness programs
• Free and discounted commuter transportation
• Applies to regular full-time positions.

Notice to Applicants

Stanford University provides job pay ranges representing its good faith estimate of what the university reasonably expects to pay for a particular job. The specific pay offered to a selected candidate will be determined based on a wide range of factors that are unique to each candidate, including but not limited to geographic work location, relevant knowledge, skills and abilities, relevant education, years of relevant experience, depth and breadth of relevant experience, and performance; further including but not limited to other business and organization needs such as the scope and responsibilities of the position, the minimum qualifications, departmental budget availability, and market and internal equity across the university, school/ unit, department, as well as job reporting relationships.

Why work at Stanford

World-changing work in a culture of continuous learning

An inspiring community that values collaboration

High-quality health and wellness benefits that put you and your family first

Access to world-class education and career development, with tuition reimbursement, training assistance, and more