Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here (https://www.myworkday.com/umiami/d/task/1422$7248.htmld) to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet (https://my.it.miami.edu/wda/erpsec/tipsheets/ER\_eRecruiting\_ApplyforaJob.pdf) . The Clinical Research Project Manager supports the Office of the Vice Provost for Research and Scholarship (OVPRS) Clinical Research Management and Support Office (CRMSO) multi-center studies across all stages of clinical development. The Clinical Research Project Manager reports to the Director, Clinical Research Management Support Office. CORE JOB FUNCTIONS + Leads cross-functional teams to ensure multi-center studies are conducted within the timeline, with quality and within budget. + Develops and maintains study timelines through collaboration with internal and external stakeholders; ensure timelines remain on track through ongoing communication, collaboration and risk-mitigation strategies. + Drives study start-up activities, including site and vendor identification, feasibility and selection for assigned studies. + Effectively models and manages patient enrollment forecasts; implement risk mitigation strategies to ensure enrollment remains on track. + Develops oversight plans for outsourced services; oversee vendors, including CROs, third-party vendors and consultants to ensure the timeliness and quality of services performed. + Reviews contracts and budgets to assess feasibility, ensuring clear understanding of project scope, costs, and expectations for successful implementation. + Reviews and approves invoices submitted by vendors and subsites, ensuring accuracy and compliance with the agreed-upon budgets and contractual terms. + Oversees monitoring and monitor performance, including adherence to the monitoring plan and applicable SOPs. + Conducts monitoring oversight visits and site engagement visits to ensure the quality of vendor and site performance. + Leads and/or contributes to study risk assessment and risk mitigation. Proactively communicate risks to study members and senior staff. + Facilitates and manages 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 timeline. + Collaborates 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. + Contributes to the writing and review of clinical documents such as protocols, informed consents, DSURs, monitoring plans and reports. + Actively contributes to and implement best practices and standards for study management; participate in the development of initiatives and process improvement within Clinical Operations + Approaches problem solving with a strategic, action oriented and positive attitude. + Assists with the development of policies, procedures and best practices in support of operational excellence. This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary. CORE QUALIFICATIONS Education: Bachelor’s degree in healthcare or equivalent combination of education, training, and experience. Certification and Licensing: One of the following certifications is preferred: CCRP, CCRC, CCRA, CHRC, RQAP-GCP Experience: • Minimum five (5) years of research experience Knowledge, Skills and Attitudes: + Strong project management skills + Communicate effectively with senior management and cross-functional teams + Advanced knowledge of research related federal regulations, guidance documents and State laws + Must be able and willing to provide excellent customer service at all times + Must be able 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. 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. Click here (https://www.hr.miami.edu/careers/eo-ada/index.html) for additional information. Job Status: Full time Employee Type: Temporary Pay Grade: A11