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The University of Southern California (USC) is actively seeking a full-time Clinical Operations Senior Project Manager for the USC+CHLA Alpha Clinic (AC), a pre-clinical/clinical infrastructure program serving USC and Children’s Hospital Los Angeles (CHLA). This program provides critical support for the development and testing of new cell and gene therapies for a variety of conditions and diseases, workforce education and facilitation of patient access to those clinical trials. The successful candidate will report to the Associate Director of Strategy and Operations for the AC and will be responsible for managing operations, services, day-to-day activities and administrative functions, as well as participating in the development of short- and long-term program strategies, tracking and reporting. This is an outstanding opportunity for an experienced project manager with a strong background in clinical research.

The USC+CHLA Alpha Clinic USC and CHLA are partnering on this exciting program, established in 2023, to promote clinical development of novel cell and gene therapies to treat a variety of human diseases. The AC has a four- part mission to: (a) advance and support clinical trials and therapeutic development for cell and gene therapies; (b) engage diverse and underserved communities in those trials and the resulting therapies; (c) provide training and education to r searchers, staff, patients, and communities; and (d) exchange expertise with other AC network sites and community partners. The AC supports and accelerates pre-clinical and clinical protocol development, IND submissions, clinical trial activation, data analysis, and reporting. We also serve as an important node in the state-wide network of Alpha Clinics supported by the California Institute for Regenerative Medicine, sharing expertise and best practices with other leading medical centers conducting cell and gene therapy trials. Furthermore, the AC provides training and actively engages the diverse communities of Los Angeles in research to improve their health. The Clinical Operations Senior Project Manager will be the senior staff member on the AC team, overseeing operations, and trainees and staff members as needed.

The successful candidate will be motivated, pro-active, resourceful, and detail oriented. The position requires excellent organizational and communication skills with the ability to be decisive and adaptable.

Job Accountabilities: ● Co-develops and drives agenda, the preparation of pre-clinical translation and clinical study protocols and reports on study status and identifies action items in multifunctional study team meetings. Participates in departmental initiatives aimed at improving process and efficiency. Attends project management meetings, providing overview of pre-clinical translation/clinical trial progress. ● Integrates, oversees and reports on information between staff and functional groups. Develops partnerships with internal and external groups with goal of increasing site performance and knowledge exchange. Acts as point of contact for programs and responds to or coordinates responses to information requests. Proactively anticipates and identifies operational, monitoring, and regulatory needs, ensuring early intervention when needed.

● Develops and implements standard operating procedures (SOP) and process improvements. Manages large, multi-site pre-clinical translation and clinical trial studies and teams. Assists in providing quality reviews of study conduct, protocols and data. Establishes and drives project timelines, monitors progress toward project goals and ensures study operations and documents are developed and implemented in compliance with FDA regulations and ICH-GCP guidelines. ● Conducts quality control reviews of protocols, study reports and associated documentation. ● Compiles project performance metrics, identifies problems through analysis, recommends corrective and preventive actions, and ensures their completion through internal and external audits. ● Stays abreast of current, relevant literature and clinical practice norms for project/program area(s), as well as any changes within legal, regulatory and technology environments which may affect SOP and any trial documentation and ensures alignment. ● Participates in marketing campaigns or events to promote programs. Coordinates distribution of program materials (e.g., newsletters, class notifications). Drafts and/or generates advanced communication items, and coordinates production (e.g., formatting, copying) and dissemination of documents (e.g., presentations, course handouts, grant proposals). ● Encourages a workplace culture where all employees are valued, value others and have the opportunity to contribute through their ideas, words and actions, in accordance with the USC Code of Ethics.

Required Qualifications: ● Minimum Education and experience: Master's degree plus 3 years of work experience in a clinical research setting ● Demonstrated experience managing preclinical translation and clinical studies and supervising others. ● Theoretical understanding of health sciences research and ICH-GCP guidelines, with experience applying policies and procedures. ● Skilled at technical documentation and scientific writing, and at assembling, organizing and conceptualizing numerical data in spreadsheets, databases, reports and presentations. ● Experience in a complex medical or academic development setting. ● Excellent communication skills – both written and verbal. ● Comfortable interfacing with highest level of university leadership and university supporters/volunteers.

● Demonstrated affinity for diplomacy and the ability to cultivate and maintain relationships at all levels. ● Practices a high level of integrity and honesty in maintaining confidentiality. ● Ability to multi-task effectively and demonstrate strong organizational skills. ● Sound judgment and decision making. ● A cooperative and team-oriented attitude. ● Effective facilitator in various settings.

Preferred Qualifications: ● Preferred Education and Experience: Master's degree plus 5+ years of work experience in a clinical research setting ● Knowledge about or experience with the development of gene and cell therapies. ● Experience in data management, including data management systems and data analytics. ● Experience in regulatory affairs (pre-IND meetings, IND modules). Follows established USC and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan.

This position is hybrid on-site and employee must report to work at the USC Health Science Campus in Los Angeles, CA when scheduled. Work hours and on-site days may be subject to change depending on business needs.

The annual budgeted salary range for this position is $107K - $133K . When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate's work experience, education/training, key skills, internal peer equity, federal, state and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations.

Minimum Education: Bachelor's degree in related field(s) Addtional Education Requirements Combined experience/education as substitute for minimum education Minimum Experience: 3 years in on-site clinical trial monitoring. Minimum Skills: Industry experience in a pharmaceutical, biotechnology, clinical research organization and/or nursing setting. Demonstrated experience managing and supervising others, using medical devices and terminology, and managing study records, finances and vendors. Theoretical understanding of health sciences research and ICH-GCP guidelines, with experience applying policies and procedures. Skilled at technical documentation and writing, and at assembling, organizing and conceptualizing numerical data in spreadsheets, databases, reports and presentations. Ability to manage and prioritize different tasks and projects, with deft interpersonal skills for communicating with all levels of staff and various individuals and groups coordinating and executing study activities. Preferred Education: Bachelor's degree And Master's degree In Neurosciences Or Public Health Or Pharmacology Or in related field(s) Preferred Certifications: Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC). Preferred Experience: 5 years Preferred Skills: Experience in data management. Excellent written and verbal communication skills to express complex ideas to study staff at research and clinical institutions. Ability to handle several priorities within multiple, complex clinical trials. Strong understanding of current GCP guidelines applicable to the clinical research conduct. Proficient in OmniPlan or other timeline applications. Familiarity with academic medical centers.