UC Irvine · 8 hours ago
Clinical Research Manager - Hybrid
Orange County, CA
Full-time
Hybrid
Senior Level
7+ years expUC Irvine is a prestigious university known for its academic achievement and research. The Clinical Research Manager will oversee operations for a clinical research initiative, managing both administrative and budget operations to meet research objectives.
Higher Education
No H1B
Responsibilities
Manages operations, including administrative and budget operations, for a clinical research initiative or clinical research program
Receives research objectives and defines subordinate goals in order to achieve those objectives
Qualification
Required
Broad academic knowledge and applied background in clinical research philosophy
Applies knowledge of theoretical concepts and business best practices in a trial setting
Proven ability to translate clinical research philosophy into direct and indirect clinical input to design, planning, initiation, execution and reporting of clinical trials
Broad knowledge of clinical research concepts, federal, state and local laws and regulations, and industry requirements regarding the proper conduct of clinical trials
Broad theoretical and operational knowledge of clinical and patient safety standards and regulations relating to clinical research
Demonstrated management skills supervising, maintaining and developing clinical staff within the study team, and acting as a mentor for professional staff and conducting reviews and performance evaluations
Effectively manages multiple important priorities
Demonstrated ability to work collaboratively with other cross-functional teams and people with a wide range of educational backgrounds
Demonstrated ability to interface with commercial, regulatory, federal and other members of an extended study team
Ability to influence / persuade
Ability to analyze, plan and control budgets; effective management of multiple fund sources
Skills to manage complex research grants, contracts and sub-contracts-budget development, contract negotiation, appropriate reporting to required entities
Advanced degree in related area and / or equivalent experience / training
Certificate in clinical research (CCRC) by ACRP or SOCRA
7- 9 years of experience
Experience at a NCI-designated Comprehensive Cancer Center
Extensive experience with various types of human subject clinical trials i.e., National Group, Industrial, and Investigator-authored
Preferred
Broad knowledge of all phases of clinical research, from study startup through closeout and primary publication and presentation
Knowledgeable about clinical studies involving complex trial design issues
Demonstrates excellent problem-solving and analytical skills
Creatively addresses complex or new problems
Proven skills to quickly evaluate complex issues and identify multiple options for resolution
Strong communicator; includes verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills
Skill in analyzing and presenting data and strategy to relevant team, governance, external consultant, and regulatory / oversight meetings
Demonstrated ability to organize research work functions in an efficient and effective manner
Great organizational skills applied to personal work and improving organization of assigned staff and trial
Expert user of the campus' clinical information and documentation application programs
Technical proficiency in project management software
Benefits
Medical insurance
Sick and vacation time
Retirement savings plans
Access to a number of discounts and perks
Company
UC Irvine
UC Irvine
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Anand Gala
CEO Roundtable Member
Bob Romney
Chancellor's CEO Roundtable
Recent News
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