Clinical Research Project Manager
University of Miami

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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 for additional information.

Job Status:
Full time

Employee Type:
Temporary

Pay Grade:
A11

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