Stanford University is seeking a Program Manager for Clinical Research (Clinical Trials Operations Manager 1) to manage the overall operational planning and activities for entire clinical trials operation for the Sean N Parker Center for Allergy and Asthma Research in compliance with GCP's, SOPs. Will supervise Clinical Research Managers and professional staff.
The Sean N. Parker Center for Allergy and Asthma Research at Stanford University is an interdisciplinary center with focus on understanding the mechanisms of the immune system, the dysfunctions of which result in allergic reactions. A leader in allergy research, our Center works collaboratively with other researchers around the world to create a data-sharing cluster of information from our interlinked satellite centers to run novel and innovative clinical trials in allergy research.
Our Center includes Stanford specialists in diverse fields including immunology, gastroenterology, otolaryngology, chemistry, bioengineering, pathology, pulmonology, and genetics. Through laboratory and computational research, clinical trials, community outreach, and other efforts, the team works toward finding rationally-based therapies to provide the safest and best treatments for allergies and asthma. Research at the Center may have implications for a wide array of immune dysfunctions including asthma, eczema, food allergies, eosinophilic disorders, drug allergies, gastroenterological diseases, and more.
Duties include:
Make decisions regarding clinical research projects, programs, and initiatives. Develop and implement research goals for a clinical trial for a department or institute providing services to multiple faculty.
Provide oversight and guidance on compliance with local, federal and international regulations on clinical research conduct.
Select, develop, and evaluate personnel to ensure the efficient operation of the function including hiring, performance management, and related duties.
Provide direction to PI's, Clinical Research Managers on staffing needs, funding and resources in order to meet the needs of individual research efforts and overall research group.
Clarify and resolve issues with substantial significance and impact, which may span multiple areas, using advanced clinical trials operations and Good Clinical Practice (GCP) knowledge.
Provide direction for the clinical sites to establish protocol development. Review clinical practices, case report forms, and reports.
Liaise with senior management ad cross functional areas and schools. Serve as a liaison to external organizations/agencies (FDA, NIH, Hospitals). Negotiate and establish external resource contracts.
Manage and coordinate assigned multi-site or large-scale clinical trials research studies conducted by a supervising principal investigator(s) in support of actives that meet objectives of assigned research protocol(s).
Access protocols internally, evaluate documentation for feasibility, conduct, and compliance. Provide expertise to improve protocol quality and completeness.
Administer the budget, assign resources accordingly and assist with grant budget proposals.
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.
DESIRED QUALIFICATIONS:
Knowledge of hypothesis-generating (omics) and experience in hypothesis-testing scientific research projects
Knowledge and experience including General clinical experience Good Clinical Practices, and Conduct of Clinical Research Studies.
Ability to run a high-quality research organization, organizing and motivating teams who perform basic science research and clinical research.
Experience developing and nurturing a growing organization, mentoring managers and project leaders, implementing processes, quality control mechanisms to ensure consistency across groups.
Experience with improving quality, implementing metrics, and reporting results.
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree plus five years of relevant experience, or combination of education and relevant experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
Demonstrated experience leading and managing clinical trial staff.
Demonstrated experience leading multi-site or large-scale clinical trials research.
Ability to run a high-quality clinical research organization, organizing and motivating teams to follow good clinical practice and regulatory requirements, while providing excellent patient care and study conduct.
Demonstrated ability to work and communicate effectively with others, collaborate and build relationships across all levels of an organization.
Project management experience in a research environment.
Strong knowledge of industry standards and/or regulatory requirements.
Knowledgeable about insurance billing, and the Medicare Coverage Act.
Knowledge and experience including Good Clinical Practices, and Conduct of Clinical Research Studies.
Excellent written, verbal, interpersonal, and presentation skills.
PHYSICAL REQUIREMENTS:
Frequently sit, grasp lightly, use fine manipulation and perform desk-based computer tasks, lift, carry, push pull objects that weigh to ten pounds.
Occasionally stand, use a telephone or write by hand.
Rarely kneel, crawl, climb, twist, bend, stoop, squat, reach or work above shoulders, sort, file paperwork or parts, operate foot and hand controls.
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:
Occasional local and overnight travel.
WORKING 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/.
Why Stanford is for you
Imagine a world without search engines or social platforms. Consider lives saved through first-ever organ transplants and research to cure illnesses. Stanford University has revolutionized the way we live and enrich the world. Supporting this mission is our diverse and dedicated 17,000 staff. We seek talent driven to impact the future of our legacy. Our culture and unique perks empower you with:
Freedom to grow. We offer career development programs, tuition reimbursement, or audit a course. Join a TedTalk, film screening, or listen to a renowned author or global leader speak.
A caring culture. We provide superb retirement plans, generous time-off, and family care resources.
A healthier you. Climb our rock wall, or choose from hundreds of health or fitness classes at our world-class exercise facilities. We also provide excellent health care benefits.
Discovery and fun. Stroll through historic sculptures, trails, and museums.
Enviable resources. Enjoy free commuter programs, ridesharing incentives, discounts and more.
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.
Why work at Stanford?Stanford University has changed the world, over and over again.We are one of Silicon Valley's largest employers - and also one of the most unique. Our mission is to educate future leaders and promote interdisciplinary, world-class research and teaching. This passion makes Stanford an intensely creative, rewarding, and challenging place to work. At the same time, our traditions of respect and collaboration sustain a humane, supportive environment in which to pursue your life and your career.At Stanford you'll work with bright, diverse, dedicated people. You'll find encouragement to learn and grow. You'll enjoy excellent benefits and an outstanding environment. How will it change you?
