Clinical Trial Manager/Senior Clinical Trial Manager

About Soleno Therapeutics Inc

Soleno Therapeutics, Inc., based in Redwood City, California, is a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, including Prader-Willi syndrome (PWS).

At Soleno, we are driven by the unique and multi-faceted needs of the PWS community. Like these individuals, resilience is part of who we are – it is in our chromosomes – and our team is made up of exceptional colleagues whose collective efforts are woven together to deliver meaningful outcomes, both professionally and for those living with PWS.

We value collaboration, integrity, and respect. These characteristics have allowed us to forge strong, authentic bonds with the caregivers, patients, health care professionals (HCPs) and community members we serve. We are proud to work alongside them every step of the way.

Our employees are our most important asset, and we are looking to expand across many functions during this important and pivotal time. We encourage you to join us in making history. We all share the most important goal of bringing solutions to the PWS community. They are waiting.

Summary of Job (brief description)

The Clinical Trial Manager reports to Soleno’s Senior Director, Clinical Operations and is a key leader in the Clinical Operations department contributing to the execution of Soleno’s clinical trials across all phases, in accordance with company goals and budgets. This individual will work closely with various internal team members and vendors as well as clinical study sites to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with the protocol(s), SOPs, ICH GCP, regulatory authorities’ regulations/guidelines, and applicable SOPs. This role requires adaptability and willingness to travel domestically and internationally as needed to support trial execution.

Responsibilities

• Manages the operational aspects of clinical trials including but not limited to timelines, budget and resources.
• Works closely with the Senior Director, Clinical Operations to ensure adequate resourcing and trial support.
• Participates in and facilitates Contract Research Organization (CRO) and vendor selection processes for outsourced activities.
• Works with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met.
• Manages CRO and vendor interactions, including sponsor oversight of operational functional activities (e.g., trial management, site monitoring and management, project master files) to ensure compliance with the contracted trial specifications and applicable SOPs.
• Participates in development and review of protocol, case report form (CRF) development, trial plans, Clinical Study Report preparation, and New Drug Application / Marketing Authorization Application (NDA/MAA) submissions, as appropriate.
• Prepares, reviews and approves trial-related tools, worksheets and documents (e.g., informed consent template, Clinical Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines).
• Prepares trial metrics and updates for management, as assigned.
• Proactively identifies potential trial issues, mitigates risks, recommends and implements solutions to ensure compliance with the protocol, SOPs, regulatory requirements and ICH GCP guidelines.
• Reviews and approves investigator clinical trial agreements and site payments.
• Organizes, attends, and manages internal team meetings, CRA meetings, investigator meetings, CRO meetings and other trial-specific meetings.
• Drives investigator selection process by development of potential investigator listing and customization of trial specific tools (e.g., Site Profile, Site Feasibility Questionnaire and pre-trial tracker).
• Works with CRO or assigns clinical research associate (CRA) to conduct pre-trial contact, review pretrial contact reports and vetting documentation to ensure compatibility with the requirements of the proposed trial.
• Provides input to the Project Director (PD) regarding investigator and site selection, notifies investigators of participation status.
• Collab