University of Miami
Clinical Research Project Manager (Clinical Trial)
University of Miami, Coral Gables, Florida, United States,
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 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 the ground breaking 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. Click here (https://www.hr.miami.edu/careers/eo-ada/index.html) for additional information.
Job Status:
Full time
Employee Type:
Staff
Pay Grade:
A11
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 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 the ground breaking 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. Click here (https://www.hr.miami.edu/careers/eo-ada/index.html) for additional information.
Job Status:
Full time
Employee Type:
Staff
Pay Grade:
A11