Clinical Trial Project Manager

Updated: 18 days ago
Location: Stanford, CALIFORNIA
Job Type: FullTime

Clinical Trial Project Manager - 75627



Description

 The Stem Cell and Gene Therapy Clinical Trial Office (SCGT-CTO) in the Division of Pediatric Stem Cell Transplantation and Regenerative Medicine, Stanford University School of Medicine, seeks a full-time Project Manager 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 all aspects of the IND process, produce progress reports, coordinate activities, and ensure that timelines and deliverables on projects are being met. 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



Qualifications

 DESIRED QUALIFICATIONS:
• Advanced degree in medical/pharmaceutical discipline, project management or business is preferred
• 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.
• Demonstrated creativity, problem solving, critical analysis, initiative, judgment and, decision-making skills.
• Demonstrated ability to develop and meet budget goals.
• Demonstrated solid planning and organizational skills.
• Demonstrated experience working independently and as part of a team.
• Excellent interpersonal, written and oral communication skills.
• Strong relevant subject matter knowledge.
CERTIFICATIONS & LICENSES:
PMP Certification or equivalent is preferred.
PHYSICAL REQUIREMENTS*:
• Constantly perform desk-based computer tasks.
• Frequently stand/walk, sitting, grasp lightly/fine manipulation.
• Occasionally use a telephone.
• 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.


Job
: Administration
Location
: School of Medicine
Department URL: http://pediatrics.stanford.edu/
Schedule
: Full-time
Grade: J
Job Code: 4122

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