Clinical Research Manager - Hybrid

University of California, Irvine • Orange, CA

8d • Hybrid

About The Position

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.

Requirements

• 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

Nice To Haves

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager