Clinical Operations DIrector

YOH Services LLC
United States, California, South San Francisco
Jan 25, 2025
Clinical Operations DIrector Category: Life Science Employment Type: Direct Hire Reference: BH-381728 Director of Clinical Operations-Biotech Location: SoSF Salary Range: 230-275 Director of Clinical Operations will be a key member of a small clinical development team that is implementing a number of early-stage clinical programs evaluating multiple investigational therapeutic drugs to treat chronic diseases. This is a hybrid role, reporting to SoSF 3 days a week Responsibilities: Develop and execute clinical trial plans using best practice management standards and methodologies Identify, select and manage Service Providers (SPs) and investigational clinical sites Serve as the main POC for SP's; manage all training and oversight Draft and coordinate reviews of study-related documents including protocols, informed consent forms, case report forms, monitoring plans, investigator brochures, and clinical study reports Develop and maintain study timelines and study budgets Contribute to the development of abstracts, presentations, and manuscripts Monitor and track clinical trial progress and upkeep of status update reports Identification of program risks and development and implementation of mitigation strategies Set up of (e)TMF, ongoing quality review and final reconciliation of study documents including review of site regulatory documents/packages Ensure GCP compliance and inspection readiness are maintained throughout study conduct Perform Sponsor quality oversight of clinical investigational staff and SPs Performance of oversight of central laboratories and other ancillary vendors during start-up, conduct, and close-out Manage, mentor less-experienced Clinical Operations staff Requirements Bachelors or RN degree 12+ years of clinical monitoring and clinical operations experience within a pharmaceutical, biotechnology, or contract research organization Previous management of clinical operations professionals Thorough knowledge and understanding of FDA and EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials. Experience with early clinical development, particularly with antiviral or anti-infectious disease compounds is preferred. Experience of partnering with Quality Management to support the development and maintenance and development of quality management system Demonstrated ability to identify potential trial level risks and develop effective mitigation strategies to proactively address them Significant experience of Service Provider selection and management Estimated Min Rate: $192500.00 Estimated Max Rate: $275000.00 Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply. Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process. For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.