Clinical Research Project Manager

1 week ago

Miami, Florida, United States University of Miami Full time

Clinical Research Project Manager Job Summary

The University of Miami seeks a highly skilled Clinical Research Project Manager to 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 multi-center studies are conducted within the timeline, with quality, and within budget.
  • Develop and maintain study timelines through collaboration with internal and external stakeholders, ensuring timelines remain on track through ongoing communication, collaboration, and risk-mitigation strategies.
  • Drive study start-up activities, including site and vendor identification, feasibility, and selection for assigned studies.
  • Effectively 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 the timeliness and quality of services performed.
  • Review contracts and budgets to assess feasibility, ensuring a 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 the 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 the 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, as well as ensure adherence to study timelines.
  • Collaborate with medical research, data management, biostatistics, pharmacovigilance, and other functions to ensure data is processed in a timely manner 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 an 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.
  • 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.

Equal Opportunity Employer

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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