Clinical Operations Manager

Clinical Operations Manager

Atom Therapeutics is focused on new drug development. We are seeking an experienced and highly motivated Clinical Operations Manager, to drive the planning, execution, and successful completion of our clinical trials. This role reports directly to the Sr. Director/VP Clinical Development and the CEO, and is ideal for candidates with a strong track record in managing global clinical trials and Phase 3 trials. .

Job Title: Clinical Operations Manager

Department: Clinical Development

Reports To Sr. Director/VP Clinical Devement 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 CRO/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 are 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 the following programs: MS Word, PowerPoint, Excel and Project
• Regularly required to sit for long periods of time and to work at office.
• Travel possible
• Salary range is from $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