Clinical Research Project Manager

1 day ago

Coral Gables, Florida, United States University of Miami Full time
Job Summary

The Clinical Research Project Manager will support the Office of the Vice Provost for Research and Scholarship (OVPRS) Clinical Research Management and Support Office (CRMSO) in managing multi-center studies across all stages of clinical development.

Key Responsibilities
  • Lead cross-functional teams to ensure timely completion of multi-center studies within budget and quality standards.
  • Develop and maintain study timelines through collaboration with internal and external stakeholders, ensuring ongoing communication and risk-mitigation strategies.
  • Drive study start-up activities, including site and vendor identification, feasibility, and selection for assigned studies.
  • Model and manage patient enrollment forecasts, implementing risk mitigation strategies to ensure enrollment remains on track.
  • Develop oversight plans for outsourced services, overseeing vendors, including CROs, third-party vendors, and consultants to ensure timely and quality services.
  • Review contracts and budgets to assess feasibility, ensuring clear understanding of project scope, costs, and expectations for successful implementation.
  • Review and approve invoices submitted by vendors and subsites, ensuring accuracy and compliance with agreed-upon budgets and contractual terms.
  • Oversee monitoring and performance, including adherence to the monitoring plan and applicable SOPs.
  • Conduct monitoring oversight visits and site engagement visits to ensure quality of vendor and site performance.
  • Lead and/or contribute to study risk assessment and risk mitigation, proactively communicating risks to study members and senior staff.
  • Facilitate and manage cross-functional interactions with internal and external stakeholders to ensure relevant and timely communication of information and materials for decision-making purposes and adherence to study timeline.
  • Collaborate with medical research, data management, biostatistics, pharmacovigilance, and other functions to ensure timely data processing for ongoing data review, interim analyses, and final database lock.
  • Contribute to the writing and review of clinical documents, such as protocols, informed consents, DSURs, monitoring plans, and reports.
  • Actively contribute to and implement best practices and standards for study management, participating in the development of initiatives and process improvement within Clinical Operations.
  • Approach problem-solving with a strategic, action-oriented, and positive attitude.
  • Assist with the development of policies, procedures, and best practices in support of operational excellence.
Requirements
  • Bachelor's degree in healthcare or equivalent combination of education, training, and experience.
  • One of the following certifications is preferred: CCRP, CCRC, CCRA, CHRC, RQAP-GCP.
  • Minimum five (5) years of research experience.
Preferred Qualifications
  • Strong project management skills.
  • Effective communication with senior management and cross-functional teams.
  • Advanced knowledge of research-related federal regulations, guidance documents, and State laws.
  • Ability to provide excellent customer service at all times.
  • Ability to communicate effectively and customer-service oriented verbally and in writing.
  • Proficient in computer software (i.e., Microsoft Office).
  • Ability to make independent judgments and act on decisions daily.
  • Ability to work for extended periods of time without direction.
  • Ability to prioritize own work and the work of others as needed.
  • Ability to work flexibly on several tasks simultaneously and meet various concurrent deadlines.
  • Extraordinarily strong organizational skills, analytical and problem-solving abilities, and attention to detail.
  • Demonstrated ability to coordinate projects independently and work constructively as part of a team.
  • Ability to maintain confidentiality.
About the University of Miami

The University of Miami offers competitive salaries and a comprehensive benefits package, including medical, dental, tuition remission, and more.

UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by groundbreaking research and medical education at the Miller School of Medicine.

As an academic medical center, we are proud to serve South Florida, Latin America, and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research, and patient care. We're the challenge you've been looking for.

The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.

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