Clinical Project Manager

Sionna Therapeutics is a clinical-stage biopharmaceutical company on a mission to revolutionize the current treatment paradigm for CF by developing novel medicines that normalize the function of the CFTR protein. Sionna’s goal is to deliver differentiated medicines for people living with CF that can restore their CFTR function to as close to normal as possible by directly stabilizing CFTR’s nucleotide-binding domain 1 (NBD1), which the company believes is central to potentially unlocking meaningful improvements in clinical outcomes and quality of life for people with CF. Leveraging over a decade of the co-founders’ extensive research on NBD1, the company is advancing a pipeline of novel small molecules engineered to correct the defects caused by the F508del genetic mutation, which resides in NBD1. Sionna is also developing a portfolio of complementary CFTR modulators that are designed to work synergistically with its NBD1 stabilizers to improve CFTR function. Position Summary: Sionna Therapeutics is seeking a Clinical Project Manager (CPM) who will be responsible for most aspects of clinical study management, overseeing the CRO and other vendors and helping to ensure the quality of deliverables. In collaboration with the Director of Clinical Operations the CPM will lead functional team members, CROs and vendors to successfully deliver clinical studies. Also, as needed, the person in this role will support and help develop clinical operations SOPs, in conjunction with QA and the Director of Clinical Operations. This position reports to the Director of Clinical Operations. Responsibilities: Oversees clinical study activities, quality, timelines and budget Participate in study start-up and ensure all startup activities, including site selection and activations are aligned with internal timelines Partner with the CRO to ensure participant enrollment targets are met Responsible for the development and management of clinical study documents including, but not limited to, protocols (and other protocol related documents), Informed Consent Forms (ICFs), confidentiality agreements Responsible for helping to develop, track, review, and manage study related plans and processes, including but not limited to Investigator agreements (CTA), clinical monitoring plan (CMP), safety monitoring plan (SMP), lab manuals, protocol deviations, etc. Oversee monitoring activities, ensure compliance with the CMP, review annotated trip reports, perform site monitoring and co-monitoring visits as needed; review of monitoring visit reports Closely oversee CRO and study vendors, as applicable, to ensure compliance with ICH/GCP requirements and internal SOPs, where applicable Opportunities to manage clinical vendors required to conduct studies When applicable, manage and work with translation vendor to prepare clinical, subject-facing documents for IRB/EC submissions Participate in data review and query management to ensure quality data and site performance in accordance with the protocol Participate in the UAT of clinical databases Responsible for oversight and maintenance of the TMF and ensuring related SOPs and TMF plans are being followed Help mentor and train junior members of the clinical team in the area of clinical operations as needed Help to ensure studies are “inspection ready” at all times Support and help to drive the development, review, approval, training, adherence to and life-cycle management of GxP SOPs Requirements: Bachelor’s degree or equivalent in health-related field preferred 5+ years of experience in the pharmaceutical/biotechnology industry which includes experience as a Clinical Study Lead Solid understanding of clinical operations process and documentation Proficiency in the areas of clinical site selection, initiation and management Understanding of ICH and regulatory environment as it pertains to clinical operations Ability to multitask and prioritize; comfortable with changing priorities Excellent interpersonal, problem-solving and organizational skills Excellent written and oral communication skills Experience with Phase 1 and Phase 2 studies, rare disease and global clinical trials is a plus Experience in working in a small organization is preferred #J-18808-Ljbffr Sionna Therapeutics