Job description

Job #1369098

***Open to Los Angeles Candidates Only***

Required Qualifications:

• Bachelor’s degree in related field
• 5 years of clinical research experience
• Experience managing clinical trials required
• 4 years managerial level experience
• Certificate in Clinical Research Professional
• Fully vaccinated and boosted for COVID (no exemptions)

Preferred Qualifications:

• Knowledge and/or experience with NCI (National Cancer Institute) CCSG (Cancer Center Support Grants ) expectations
• Previous experience coordinating and managing oncology clinical research programs

Position Summary:

The Senior Manager provides strategic leadership to the clinical, regulatory, and financial units. Directs managers/supervisors assigned to these units by establishing and implementing operational standards and monitoring progress and compliance. Serves as the subject matter expert on best practices on clinical trial management, regulatory requirements. Accountable for the strategic growth and continued success, in collaboration with the Executive Director andMedical Director. Works collaboratively to develop, implement, and maintain the infrastructure necessary to support National Cancer Institute (NCI) designation.

Job Duties:

• Responsible for strategic planning, organizing and oversight including development for patient recruitment, compliance, performance and quality improvement, operational improvement, and employee engagement.
• Oversees clinical research staff
• Oversees financial resources, development, and management of clinical trial budget
• Lead the cross-functional study team responsible for the global execution of clinical trials from study design through study close out (internally sourced and studies outsourced to CROs)
• Responsible for managing Third-Party Vendors and CROs
• Provide operational input into protocol development
• Leading all aspects of and contributing to the development of study specific documentation e.g. case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc
• Supervising set-up and maintenance of study systems such as Clinical Trial Management System (CTMS), Trial Master File (TMF) etc
• Providing input into baseline budget and timeline development and managing the study against planned budget, timeline and results
• Leading risk assessment and identifies risk mitigation strategies at the study level
• Managing feasibility assessment to select relevant regions and countries for the study
• Conducting site evaluation and selection
• Leading investigator meeting preparation and execution
• Monitoring progress for site activation and monitoring visits and acts on any deviations from plan
• Managing development and implementation of patient recruitment and patient retention strategies

Note: Hourly payrate is dependent on experience.

Job Types: Full-time, Contract, Temporary

Pay: From $55.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• Day shift

Ability to commute/relocate:

• Los Angeles, CA 90025: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

• How many years of interim leadership experience do you have?
• What EMR/EHR systems have you worked with?
• Do you have work history gaps of more than 30 days? If yes, please provide dates and explanations.
• Please list any professional certifications you hold.
• What is your permanent address (if desired to travel outside of 55 miles)?
• What is your COVID-19 Vaccination Status? If not vaccinated, do you have a religious or medical exemption?

Education:

• Bachelor's (Required)

Experience:

• clinical research: 5 years (Required)
• managerial level: 4 years (Required)
• Clinical trials management: 1 year (Required)

License/Certification:

• Clinical Research Professional Certificate (Required)

Work Location: In person

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