Manager, Clinical Research (Myeloma)
Manager, Clinical Research (Myeloma)
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Job Description
Current Employees:
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The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full Time Manager Clinical Research to work at the UHealth medical campus in Miami FL.
CORE JOB SUMMARY
The Manager Clinical Research oversees the development of clinical trials and research programs that support the overall mission of the University. This role is also responsible for the independent execution of regulatory-related decisions/strategies and coordinates work with study managers and other relevant team members to assure the fidelity of study protocols and data collection.
CORE JOB FUNCTIONS
1. Works with investigators and study teams to help meet targets and milestones ensures timely and accurate submission to IRBs sponsors and master agreements and coordinates with the Research Program Director on remediation.
2. Coordinates the efforts of relevant team members to manage retain and control all applicable Regulatory Affairs submissions pertaining to University held INDs and IDEs as well as exemption requests.
3. Assembles project plans team and work assignments directing and monitoring work efforts on a daily basis identifying resource needs performing quality review and escalating functional quality and timeline issues appropriately.
4. Manages investigator relationships.
5. Maintains IND and IDE documentation including annual reports for delegated studies and works with the primary investigator and project team to assist in responding to queries from regulatory agencies including the FDA.
6. Tracks proposals and other study relevant documentation through signature/approval processes then through collaboration with Contracts and budgets.
7. Serves as liaison and facilitates meetings between project stakeholders and leadership and completes and maintains professional documentation for projects and deliverables develops SOPs as needed and assists in the auditing and monitoring of studies.
8. Identifies areas for improvement within daily functions internal procedures and regulatory agency interactions.
9. Interacts with project team members to define submission logistics and workflow scheduling.
10. Oversees the ongoing maintenance of records detailing the number of active INDs and IDEs and related data via an internal tracking system.
11. Prepares and presents the annual summary report for clinical trial and research areas.
12. Provides consultation and guidance for UM held INDs and IDEs.
13. Develops implements maintains and oversees internal policies and SOPs as well as Universitywide policies and SOPs intended to assist University researchers in maintaining compliance with FDA regulations and other Clinical Research Best Practices.
14. Establishes and continuously assesses the effectiveness of the internal controls within the unit and compliance with University policies and employees are trained on controls within the function and on University policy and procedures.
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:
Bachelors degree in relevant field required
Experience:
Minimum 5 years of relevant experience required
Knowledge Skills and Abilities:
- Operational Management: Optimizes day-to-day operations and processes for efficiency and effectiveness.
- Organizational Development: Ability to implement strategies to improve organizational effectiveness engagement and manage change.
- Financial Oversight: Knowledge of financial operations and management.
- Team Leadership: Ability to create and maintain a cohesive and productive team environment build positive working relationships and work collaboratively with others.
- Technical Proficiency: Skilled in using office software technology and relevant computer applications.
- Communication: Strong verbal and written communication skills to convey ideas clearly and persuasively.
Department Specific Functions
The Manager of Clinical Research is responsible for overseeing various clinical research programs with a particular focus on non-interventional clinical research studies for the SCCC Myeloma Institute. This role ensures operational excellence regulatory compliance and high-quality execution of research protocols across projects specific to the Myeloma Institute.
- Oversees day-to-day operations of non-interventional research programs for the SCCC Myeloma Institute ensuring adherence to institutional state and federal guidelines.
- Devises new algorithms and pipelines to enhance research efficiency data integration and analytical accuracy.
- Manages translational clinical research operations and quality assurance procedures for specimen collection curation analysis and interpretation.
- Ensures protocol compliance IRB submissions and study documentation meet internal and external regulatory requirements.
- Supports the planning and execution of non-interventional non-treatment clinical research programs including registries observational studies and biobanking initiatives.
- Collaborates with cross-functional teams including investigators data managers statisticians and lab staff to align research objectives and timelines.
- Supervises and mentors research staff fostering continuous learning and professional development.
- Works closely with the Associate Director of the Myeloma Institute PIs and Director of Administrative Operations for day-to-day research tasks.
- Aid myeloma principal investigators in development of non-interventional clinical and translational research structure
- Assist the Division in its expanding and growing translational and exploratory research focusing on investigator-sponsored studies by coordinating and developing these studies their assays and collections
- Directly aid the Myeloma Institutes Associate Director for Clinical Research to help support in a cross-collaborative manner all the basic science and clinical Principal Investigators.
- Manages investigator relationships as it pertains to industry and non-profit collaborators.
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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 Floridas 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. Were the challenge youve 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 for additional information.
Job Status:
Full timeEmployee Type:
StaffPay Grade:
A13Required Experience:
Manager
Employment Type
Full-Time
