Senior Clinical Project Coordinator

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:

• Working with the Clinical Study Lead (CSL), other study team members and the CRO, collect, distribute, track and file clinical study documentation
• Manage eTMF set-up, maintenance and completeness reviews in accordance with the TMF Plan
• Support study start-up, maintenance and close out activities as directed by the CSL, including Protocol Deviation review, ICF updates, and creating study plans, as needed
• Assist with CRO/vendor management to help ensure proper oversight
• 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 and Sourcing teams on invoicing and change order processing
• Track screening and enrollment activities for assigned study(ies) and provide updates in meetings as appropriate
• Help perform User Acceptance Testing (UAT) for clinical databases, as needed
• As needed, assist with study sample shipments and clinical supply shipments
• Collaborate cross-functionally to assist with study timeline adherence and deliverables
• Coordinate study team meetings, distribute materials and agendas, track action items, as needed
• Help to ensure studies are always “inspection ready”
• Additional tasks as needed

Requirements:

• Bachelor’s degree or equivalent in health-related field preferred
• 6+ years of relevant experience in the pharmaceutical/biotechnology industry; 3+ years as a Clinical Project Coordinator
• 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

Salary Range: $95,000 – $120,000