Senior Clinical Project Coordinator na Sionna Therapeutics Inc

Description

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 Senior Clinical Project Coordinator (Sr. CPC) to support the day-to-day execution of clinical studies. This role will be responsible for coordinating essential study documentation, managing the electronic Trial Master File (eTMF), and contributing to the development and maintenance of clinical operations templates and Standard Operating Procedures (SOPs) in collaboration with Quality Assurance (QA) and the Director of Clinical Operations.  This role reports to the Director of Clinical Operations.

Responsibilities:

• In conjunction with the Clinical Study Lead, collect, distribute, track and file clinical study information
• Manage eTMF set-up, maintenance and completeness reviews in accordance with the TMF Plan
• Perform and document the QC of clinical study documents prior to finalization, as needed (protocol, ICFs etc.)
• Distribute copies of finalized study documents (protocol, IB etc.) to vendors and internal team members, as needed
• Assist with the tracking and management of clinical study-related contracts, budgets and Purchase Orders, working closely with the Finance team on invoicing and change order processing
• Track screening and enrollment activities for assigned studies and provide updates in meetings as appropriate
• Perform User Acceptance Testing (UAT) for clinical databases, as needed
• As needed, assist with reconciliation of clinical supply shipments and sample discrepancies 
• Collaborate cross-functionally to assist with study timeline adherence and deliverables
• Coordinate study team meetings, distribute materials and agendas, track action items
• Help to ensure studies are “inspection ready” at all times
• Additional tasks as needed

Requirements

• Bachelor’s degree or equivalent in health-related field preferred
• 3+ years of experience in the pharmaceutical/biotechnology industry
• Knowledge of clinical operations processes and documentation 
• Strong organizational skills and attention to detail
• Basic knowledge of GCP/ICH as it pertains to clinical operations 
• Ability to work in a small organization and multitask with changing priorities
• Excellent interpersonal, problem-solving and organizational skills 
• Excellent written and oral communication skills