Research Project Manager

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Dept: Research Operations

• What Awaits You?
• * Career growth and development
• * Diverse and collaborative working environment
• * Affordable and comprehensive benefits package

Johns Hopkins All Children's Hospital is a premiere clinical and academic health system, providing expert pediatric care for infants, children and teens with some of the most challenging medical problems. Ranked in multiple specialties by U.S. News & World Report, we provide access to innovative treatments and therapies. With more than half of the 259 beds in our teaching hospital devoted to intensive care level services, we are the regional pediatric referral center for Florida's west coast. Physicians and community hospitals count on us to care for critically ill patients and perform complex surgical procedures.

POSITION SUMMARY

The Project Manager plans, schedules and manages assigned projects to achieve organizational objectives within defined timeframe, scope and budget. Responsible for project work plan development, establishment of project communication and risk management plans, workflow process redesign, metric development and measurement, and return on investment analysis. Works closely with the institutes, departments, clinical and non-clinical departments on organizational projects. Assists in the planning and operational readiness of projects to ensure the desired outcome is achieved. The Project Manager assigns project tasks to designated team members. Identifies and escalate issues as appropriate. Uses project management tools and standards as outlined by the Project Management Institute to ensure projects stay on track to complete deliverables and project integration with other JHACH initiatives.

Accountabilities:

1. Manage overall operation of multi-center studies through the entire project life cycle (from start-up to close-out) including project planning, budget, and resource management.
2. Serves as primary contact for overall Principal Investigator, participating sites, and/or functional area representatives (e.g. Central Biorepository, Investigational Drug Services, Data Coordinating Center) in managing protocol execution.
3. Establishes study milestones and ensures accurate tracking and reporting of study metrics. Accountable for maintenance of study information on a variety of databases and systems. Prepare project management reports for Principal Investigators and management.
4. Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues. Develop contingency planning and risk mitigation strategies to ensure successful delivery of study goals.
5. Ensures that trial timelines, costs, and quality metrics are met.
6. Ensures compliance with GCP, relevant SOP's, and regulatory requirements.
7. Plan, coordinate and present at internal and external meetings.

QUALIFICATIONS:

• Bachelor's Degree in related field
• 5 years of related and progressive experience.
• 3 years of project management experience
• PMP certification or Agile PM certification required and/or to be obtained within one year
• Demonstrates strong project/program management skills, leadership attributes - strategic thinking, ability to drive business change, sharing of organizational goals, leading multidisciplinary groups
• Ability to multi-task with excellent organizational skills
• Effective communication and presentation skills
• Knowledge of project management, process redesign techniques and skills, audit techniques, financial analysis, problem solving, change management and customer service skills
• Working knowledge of Visio, MS project, Microsoft Excel and PowerPoint, Microsoft Access, and other programs as appropriate
• Ability to communicate effectively, both verbally and in writing. Reads, writes, speaks and understands English

• Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements
• A strong understanding of the clinical trial/drug development process
• Experience working in a highly regulated environment with a strong understanding of ICH/GCP

Important Notices:

***Effective January 1st 2022, you must be fully vaccinated with an FDA COVID-19 vaccination and provide proof of your vaccination status as part of your occupational health screening. Exceptions to the COVID-19 vaccination requirement may be granted to individuals for religious beliefs or medical reasons by following the proper protocols. Effective 6/1/23, employees at Johns Hopkins All Children's Hospital, its affiliate locations and Florida State Residents are not required to obtain the COVID-19 vaccine. In the wake of the COVID-19 pandemic, the Johns Hopkins Health System remains committed to providing the highest quality care for our patients and our communities. We encourage you to explore our current opportunities.

***Authorization to Work in the United States: Applicants who require sponsorship now or in the future will not be considered for this position.

Johns Hopkins Health System and its affiliates are drug-free workplace employers.

We are committed to providing a healthy and safe environment for our patients, visitors and staff members. The Johns Hopkins Hospital has a tobacco-free at work policy. Employees must refrain from using any tobacco products during their work shifts - including while at lunch or on breaks, and whether they are on or off campus.