The Division of Pediatric Cardiology at 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 Investigational New Drug 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.
Will oversee planning and operations for the TEAMMATE (Tacrolimus and Everolimus Against. Mycophenolate Mofetil in Pediatric Heart Transplantation to Reduce Major Adverse Transplant Events) Trial Clinical Coordinating Center (CCC) located at Stanford - $10 million trial across 25 sites, including directing protocols and timeline schedules.
Works closely with Data Coordinating Center Project Director (DCC) at Boston Children's Hospital (BCH) to make sure all trial related projects/concerns are discussed and actively resolved/completed.
Works collaboratively with the DCC/BCH to develop agenda, lead discussion, and update trial website (Open Atrium) in a timely manner.
Work with Clinical Coordinating Center (CCC) and DCC to send trial enrollment/site updates every week.
Coordinate Food and Drug Administration (FDA)-related activities include: a) Investigational New Drug (IND) annual updates, b) amendment submissions, c) communicate with FDA regulatory project manager to retrieve accurate trial information or answers to trial questions.
Work with Health Canada to keep active Clinical Trial Application (CTA) and submit any required reports for the trial.
Work with central Institutional Review Board (IRB) Lead at Stanford, Boston and DCC to make sure information is submitted to the central IRB (Boston Children's Hospital) and FDA in a timely manner and versions are harmonized.
Maintain an ongoing task list for the trial.
Provides 24 hour assistance to sites for any trial related issues and knows to seek advice from co-Chairs.
Provides resources/tools to all sites to minimize protocol deviations and help study coordinators meet study goals.
Review enrollment data, modify goals as needed, and encourage sites to meet targets.
Plan and facilitate regular project team meetings involving technical resources, support staff, vendors, and business users; regularly publish minutes and status reports to study email list.
Plan and Facilitate meetings and required communication with internal and external stakeholders. Lead preparation of vendor requirements, project scope and selection of study vendors - effectively manage interactions with vendor study team.
Plan and facilitate discussions and reporting to Regulatory agencies (FDA) and committees as relevant to the IND and clinical trial.
Foster and maintain good working relationships with all clinical sites, local IRBs, Stanford entities (e.g. Grants Management, Contracts), CCC staff, collaborators (pharmacist, nephrologist, transplant coordinators), FDA, Health Canada and other key stakeholders (internal & external).
Co-manage a multimillion-dollar budget with Boston Children's Hospital. Work with Research Administrators regarding grants and with CTO leadership regarding clinical trials to ensure project is within budget.
Facilitate grant/funding preparation and maintain financial/budget documentation. Partners with cross-functional teams to manage, adjust, and revise project timelines/budgets as necessary. Update team regularly on budgetary and financial impacts of project decisions.
Oversee protocol training for sites and update sessions for new PIs, study coordinators. Develop in-service presentations on behalf of project PIs regarding how products move within the University and to each patient. May present material on behalf of PIs to internal teams.
Author, audit and/or edit training material. Project Manager will develop project-specific protocol training with wet-lab teams for non-clinical and clinical staff members (e.g. coordinate with CTO to contribute to development of study training for Laboratories and Clinical staff).
Contribute to the development of abstracts, grants, presentations, and manuscripts. Author and review grants for future funding of clinical trials, assist with any presentations by study team members, and contribute to and review manuscripts as directed by the PI.
* - Other duties may also be assigned
Advanced degree in medical/pharmaceutical discipline, project management or business is preferred.
Knowledge of Food and Drug Administration (FDA), California Institute for Regenerative Medicine (CIRM) and Stanford processes, regulations and procedures.
Knowledge of and experience with project management, including utilization of project management tools such as Gantt Charts.
Firm understanding of the research processes including but not limited to; the development of protocol, implementation of a successful research project, and management of research associates (RAs) 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 Clinical Research Organization (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 to ten years' experience managing sites participating in multicenter clinical trials
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 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:
Project Management Professional (PMP), Association of Clinical Research Professionals (ACRP), Society of Clinical Research Associates (SoCRA) Certification or equivalent is preferred. PHYSICAL REQUIREMENTS*:
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.
Location: School of Medicine, 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.
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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, 9000 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 University is an eq...ual opportunity employer and is committed to increasing the diversity of its faculty. It welcomes nominations of and applications from women, members of minority groups, protected veterans and individuals with disabilities, as well as from others who would bring additional dimensions to the university’s research, teaching and clinical missions.