Sr Clinical Trial Manager - Clinical Operations
Clinical Operations | Brisbane, CA | Full Time
At Arch Oncology, we are aiming high to discover and develop new antibody therapeutics to treat patients living with cancer. Our best-in-class anti-CD47 antibody, AO-176, is highly differentiated, with the potential to improve upon the safety and efficacy profile relative to other agents in this class. AO-176 works by blocking the “don’t eat me” signal, the standard mechanism of anti-CD47 antibodies. Beyond blocking this signal, AO-176 also directly kill tumor cells. Importantly, it preferentially binds to tumor cells, instead of to normal cells, and binds more potently to tumors in their acidic microenvironment (low pH), offering a potential safety advantage. AO-176 is currently in a Phase 1 clinical trial for the treatment of patients with solid tumors. Behind AO-176, our research team is developing a pipeline of antibodies with best-in-class profiles for the treatment of patients with cancer.
We are aiming high in our fight against cancer. We are a team of highly experienced and driven professionals who are committed to excellence in all that we do. Our leadership team has successfully developed new drugs before. We know what we need to do to collaborate and execute to get the job done.
If you share this commitment and want to work with a team that is focused on helping patients, come aim high with us and apply.
Position Location: At Arch Oncology, we have two bases. Our headquarters is in Brisbane, CA, a gateway of biotechnology innovation, and our scientific research laboratory is in St. Louis, MO, home of the Gateway Arch. This position is in Brisbane, CA.
Reports To: Vice President Clinical Operations
Position Summary: The Senior Clinical Trial Manager (Sr. CTM) performs project management activities and provides daily management of multiple study activities. The Senior CTM is responsible for setting up and managing functional aspects of studies including Clinical Research Organization (CRO) selection/oversight, investigational product, lab sample, and financial accountability. The Senior CTM may also be responsible for monitoring clinical sites or to assist in oversight of monitoring to verify that the rights and well-being of human subjects are protected; that the reported trial data are accurate, complete, and verifiable from source documents; and that the conduct of the clinical trial is in adherence to protocol, GCP/ICH, and SOPs.
Level: This role is the highest level in the Clinical Trial Manager job family.
It may supervise:
- Associate Manager, Clinical Trials
- Clinical Project Coordinator
Job Description and Responsibilities:
- May act as an independent study level
- May lead and facilitate Clinical Sub Team Meetings with lead medical monitor
- Plans, executes, and/or assists in study start-up activities (globally or regionally), including
- CRO and vendor identification and selection
- May be involved in the CRO and vendor task order development and budget negotiation
- CRO and vendor identification and selection
- Author and/or review/edit and approves key study plans and materials including:
- Monitoring Plan, Protocol Deviation Management Team Plan, eTMF Management Plan. Communication Plan, and CRF Completion Guidelines
- Site Initiation and Investigators' Meeting Presentations
- Essential document templates: Informed Consent forms (master and regional adaptions)
- Other protocol-specific tools, as required
- In collaboration with Translational Medicine; assist in the development and review of Laboratory Manual, tracking of lab supplies and assisting with lab sample discrepancies
- In collaboration with Clinical Drug Supply, assist in the development and review of Pharmacy Manual and overall drug supply for a study
- Partner with and oversee CRO team hired to support trial
- Regularly attend team calls
- Provide continuous direction and training
- Perform on-site co-monitoring or oversight visits, as needed
- Clearly communicate and effectively collaborate with external vendors and development partners (both in writing and verbally), including financial oversight
- Oversee and/or manage clinical study files/documents within electronic and/or paper Trial Master file
- As required, participates in the development, review and implementation of departmental SOPs and processes
- Identifies and/or implements process improvement ideas
- Oversees and/or manages the investigator grant process for clinical sites (site contracts and budget)
- Creation of negotiating parameters (CRO, as necessary)
- Ensuring timely site payments
- Lead or assist in the development/review of the protocol, IB, and CRF development and finalization
- Oversee CRO and/or contractors in completion of monitoring tasks and/or independently performs pre-site selection and site initiation visits; may conduct other on-site visits as required (eg, IMVs, COVs, co-monitoring visits)
- Reviews study monitoring reports, as required, and follow-up of specific issues within project specific timelines
- Develops and maintains excellent cross-functional relationships; leads ad hoc internal meetings as necessary
- Recommends and implements innovative process ideas to impact clinical trials management and success
- Direct line manager of Clinical Trial Managers (CTMs) and Associate Manager, Clinical Trials or Clinical Project Coordinators
- Oversees and manages work of Clinical Operations contractors and CRO/vendor team members
- May lead and manage Study Management teams
- May manage the work of cross-functional team members in support of study deliverables
Education and Experience:
- Bachelor’s level degree in life sciences, pharmacy or nursing; RN preferred
- Prior related clinical research experience (7+ years) in the Pharma/Biotechnology
- Prior related clinical trial management experience (3+ year) including experience managing director reports
- Oncology experience preferred; phase 2-3 trial experience required- multi-national experience a plus
- Experience managing outside vendors, e.g., CROs and labs
- Familiar with advanced concepts of clinical research and able to work effectively in a dynamic team/matrix environment
- Prior experience working with Translational Medicine/Science
- Knowledge of clinical research operations, including interpretation and implementation of FDA regulations and ICH GCP (E6) is required
- Desired soft-skills: Flexible, detail-oriented, innovative, diplomatic, and efficient
- Knowledge of the principles and practices of basic computer applications used in general office setting, including word processing, spreadsheet, database management, presentation software, and internet search engines
- Advanced capabilities with Microsoft PowerPoint, Word, Excel and Project desired
- Basic math and standard business level English grammar and usage
- Able to travel approximately 20% overnight (50% or greater during peak times)
Benefits: Arch Oncology offers a generous benefits package including medical, dental, vision, and disability insurance, as well as paid time off and a 401k plan.
Arch Oncology is an Equal Opportunity Employer and does not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.