Grade: J FTE: 100% The Center for Definitive and Curative Medicine, Stanford University School of Medicine, seeks a Clinical Trial Project Manager (ASA2) to provide planning, monitoring, and managing of investigator-initiated clinical and translational research projects, from initiation through completion; ensuring on-time completion according to specifications and within budgeted costs. S/he will oversee timing of the IND process, produce progress reports, coordinate activities, and ensure that timelines and deliverables on projects are being met. Where necessary, s/he will also work with the sponsor to generate all necessary reports and data analysis. This involves the management of complex, multifaceted projects and oversight of all functional areas involved in delivery of various aspects of clinical programs/studies while meeting collaborators needs and adhering to the program guidelines. The SCGT-CTO is a specialized entity with expertise in phase I/II clinical trials with cellular products. Stanford School of Medicine strives to lead the biomedical revolution by fueling discovery and innovation to advance human health. Duties include:
Lead the planning and operations for functions or programs that have significant business, regulatory and/or technical challenges requiring subject matter expertise.
Evaluate programs, policies and procedures. Identify issues, and develop alternative solutions which may include changes to programs, policies and procedures.
Review and analyze trends to advise and develop recommendations to achieve or modify the goals of the program or function.
Represent the project or function within the department, unit or school. Represents the program or function at the university level and/or to external constituencies.
Manage and contribute to the development of outreach strategy that may include relationship development, communications and compliance.
May develop and/or oversee budgets; manage finances including monitoring, analyzing, forecasting, and reporting.
Assess training needs and may develop associated training.
May direct and/or supervise staff.
* - Other duties may also be assigned DESIRED QUALIFICATIONS:
Advanced degree in medical/pharmaceutical discipline, project management or business is preferred
Background in cardiovascular research
Knowledge of FDA, CIRM and Stanford processes, regulations and procedures.
Ability to produce Gantt Charts for project management
Firm understanding of the research process including but not limited to; the development of protocol, implementation of a successful research project, and management of RA's using project plans and coordinating teamwork assignments in the field
10 or more years of relevant work experience - i.e., in clinical research, device development, pharmaceutical industry etc.
5 years of team lead project management experience in a CRO or device/pharmaceutical setting
Relevant work experience at an academic institution.
Ability to manage multiple priorities in a fast-paced, deadline-driven environment.
Demonstrated project management ability to employ integration, scope time management, cost, quality, human resources, communications, risk, and procurement components.
Ability to balance customer expectations with project reality.
Demonstrated resilience, diplomacy, influence, relationship building, and problem solving skills in a variety of situations.
Keen grasp of interpersonal and impact awareness.
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree and five years of relevant experience, or combination of education and relevant experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
Demonstrated ability to establish priorities, manage shifting priorities, and handle numerous time-sensitive projects with multiple deadlines.
Ability to accomplish goals working through formal and informal channels, with diplomacy and tactfulness.
Rarely lift/carry/push/pull objects that weigh 11-20 pounds.
* - 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. Additional Information
Location: School of Medicine, Stanford, California, United States Schedule: Classification Level:
Stanford is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.
Copyright 2017 Jobelephant.com Inc. All rights reserved.
Located between San Francisco and San Jose in the heart of Silicon Valley, Stanford University is recognized as one of the world's leading research and teaching institutions. Leland and Jane Stanford founded the University to "promote the public welfare by exercising an influence on behalf of humanity and civilization." Stanford opened its doors in 1891, and more than a century later, it remains dedicated to finding solutions to the great challenges of the day and to preparing students for leadership in a complex world. The University's thriving diverse community is comprised of nearly 7000 undergraduate students, 12000 graduate students, 2000 faculty members, 1900 postdoctoral scholars, and over 11,000 academic and administrative staff in seven schools including several interdisciplinary research centers and institutes. The campus spreads over 8000 contiguous acres and nearly all undergraduates live on campus. Stanford offers bachelor's and master's degrees in addition to doctoral degrees (PhD, MD, DMA and JD) plus a number of professional and continuing education programs and certifications. More at http://facts.stanford.edu and http://www.stanford.edu. Stanford is an equal empl...oyment 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. Stanford also welcomes applications from others who would bring additional dimensions to the University’s research, teaching and clinical missions.