Clinical Operations Manager

Clinical Operations Manager Department: Clinical Development Reports to: Sr. Director/VP Clinical Development and CEO Base: Newark, CA Position Purpose As the Clinical Operations Manager, you will be responsible for full‑cycle oversight of one or more clinical trials, ensuring all projects are executed within the timeline and budget. You will manage cross‑functional teams and oversee CROs/vendors. You will ensure all clinical trial activities, including database clean‑up before database lock, are conducted in compliance with the protocol, standard operating procedures (SOP), good clinical practices (ICH GCP) and other applicable regulatory requirements. You will also monitor all the invoices and budgets from CROs and vendors. Strong initiative, communication, and follow‑through are essential for this role. The ability to maintain confidentiality and operate with the highest ethical standards and professionalism is required. Key Responsibilities Participate in the development of protocols, ICFs, study plans, CRFs, patient materials, CSRs, and NDA submissions. Manage CRO interactions, including oversight of activities such as site management, site payment, sample logistics, clinical trial supply logistics, IP management, TMF, budgeting, and contract negotiations. Proactively identify potential study issues/risks and recommend solutions. Manage clinical monitoring activities, review monitoring visit reports, and oversee the follow‑up on action items by CRAs. Serve as a liaison and resource for investigational sites. Participate in the selection, training and evaluation of study personnel (contract and internal) to ensure efficient operation. Perform other duties as assigned. Qualifications At least 5+ years of experience in clinical trial operation and a BS or BA degree in a relevant scientific discipline. Knowledge of FDA and/or EMA regulations, ICH Guidelines, and GCP governing the conduct of clinical studies. Excellent computer skills in MS Word, PowerPoint, Excel and Project. Regularly required to sit for long periods of time and work at office. Travel possible. Salary range: $120,000 – $180,000. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Equal Opportunity Employer #J-18808-Ljbffr BioSpace