Sr. Clinical Trial Manager

About The Role

This position will provide clinical trial management support for ongoing and future clinical trials in our lead program. Candidate will function as the Clinical Trial Lead across several studies that is managed in-house by the Septerna Clinical Operations Team. Partnering closely with the cross-functional stakeholders (Clinical, Regulatory, Product Development), you will apply strong clinical and project management fundamentals for the implementation of various aspects of our clinical trials. The Clinical Trial Manager (CTM) will play a key role in the planning, execution, and management of clinical trials. This includes overseeing the operational aspects of the trials from start-up through close-out, ensuring trials are conducted in compliance with GxP regulations, company policies, and standard operating procedures (SOPs)

Essential Functions

• Sr. Clinical Trial Manager will be responsible for managing various aspects of clinical trial conduct with internal cross functional team members involving clinical development, contract vendors, and regulatory to achieve clinical trial goals on time and within budget
• Develop internal tracking and reporting tools for reporting study status to Leadership and facilitate internal clinical study team meetings
• Co-development and management (review, revision, tracking and filing) of study materials, including but not limited to:
• Protocols, regulatory submissions, informed consent, site budgets and agreements, training materials, newsletters, presentations for various stakeholders
• Developing (or overseeing the development of) all training/day to day materials, including SIV materials, Investigator Meeting materials, Amendment Training Materials, and any other trial-specific trainings
•  Leadership of assigned meetings (cross-functional (internal), vendor, and/or investigator) and provision of regular updates on study status, e.g., agenda development, minutes curation and filing
• Collaborate with Data Management Vendor to develop/review eCRF and completion guidelines as well as conduct user acceptance testing prior to release.
• Oversee data entry timelines and query management, including metric reporting.
• Participate in site monitoring visits as necessary
• Provide oversight and management of regional CRO assigned Clinical Research Associates (CRAs) including review of site visit reports and training records.
• Contribute to the development and refinement of clinical trial processes and procedures.
• Develop and maintain (or oversee) the development of the Trial Master File, ensuring the final TMF is final and audit ready at the close of the study
• Participate and support all audit, SOP and quality activities, the vendors, the sites, etc. to ensure alignment and consistent quality exist across the trial
• Facilitate and manage productive team communication and collaboration, both internally and externally.

Qualifications

• The ideal candidate should have a minimum of a bachelor’s degree in the life sciences and 5-8 years of direct and progressive experience specific to biotech clinical trial management with a track record of successful management of complex programs using multiple external vendors.
• Global clinical trial management strongly preferred
• "Early-stage clinical trial experience is a plus, but not a prerequisite
• Strong working knowledge of ICH-GCP guidelines, FDA regulations, and international regulatory requirements
• High attention to detail.; ability to manage multiple projects simultaneously.
• Build and preserve relationships with colleague’s investigator site staffs and clinical trial partners
• Candidates should have experience with Microsoft office programs and web-based data entry platforms.
• Candidates should have a passion for learning, creating, relating, communicating, and helping drive the success of cross functional teams.
• Ability to travel to clinical sites as needed.

The anticipated salary range for candidates who will work in South San Francisco, CA is $165,000 - $180,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training. Septerna's compensation package also includes benefits, stock options, and annual target bonus for full-time positions.

Salary : $165,000 - $180,000