Senior Clinical Trials Manager

About the Company:
We are developing first-in-class therapies designed to reprogram the immune system to achieve antigen-specific tolerance for immune-mediated disease. Our platform of immune-modifying nanoparticles aims to treat the root cause of immune disease, unlike traditional approaches, which only minimize symptoms using toxic immune suppression.

About the Role:
Reporting to the Head of Clinical Operations, the Clinical Trial Manager (CTM) is responsible for the overall management and oversight of assigned clinical trials and clinical research. The CTM will be a key contributor to develop study-related documents and create standards and guidelines for clinical research studies and programs ensuring adherence to standard operating procedures, ICH-GCP, and FDA regulations.

Responsibilities:
Assume overall responsibility for the preparation of project documentation and Case Report Forms, finalization of monitoring and data management options, ethics committee approval, development of recruitment strategies to increase patient randomization into clinical trials, the provision of clinical trial materials, and management of these trials.
Ensure projects follow GCP-ICH guidelines, Company and/or CRO SOPs and any local applicable regulations; liaise with internal department managers and/or external CRO team members as necessary (i.e., data management, quality, clinical supplies, CRO project manager).
Coordinate the monitoring of all trials by identifying and managing qualified staff, establishing audit procedures, and ensuring that cleaned data is entered into the database in a timely fashion.
Ensure the smooth running of the clinical operations by developing systems to track projects including all study, investigator and ethical review board information, patient recruitment activity and financial management (may be internal or via external CRO system).
Coaching/training of CRAs in various aspects of specific clinical trials that are relevant to project issues.
Review, assess and assure completion of training by CRAs and other clinical staff with topics that include principles and practices of clinical project management, team communication, applicable systems, and IT training.
Contribute to protocol development; oversee CRF writing, adverse event reporting, work closely with Medical Monitor(s) for proper safety reporting and ensure accurate budget control processes and reporting for COUR Leadership.
Administration and oversight of study budgets with vendor(s).
Manage projects in accordance with the contract, proactively recognizing any changes in scope and collaborating with senior management to ensure timely completion of change orders.
Effectively manage project budgets to ensure financial targets are met through regular reviews of indirect costs and project resources and by collaborating with Finance to ensure accurate revenue recognition.
Oversee and track progress of site identification, start-up, monitoring, and study close-out activities, including managing third-party vendors and/ or contract CRAs.
Assist in development of key operational processes, internal training and communications on processes as required.
Manage projects in a timely manner, in compliance with GCP-ICH guidelines, Company and/or CRO SOPs and any local applicable regulations; liaise with internal department managers and/or external CRO team members as necessary (i.e., data management, quality, clinical supplies, CRO project manager).
Participate in process improvement initiatives as requested.

Requirements:
Four-year degree or equivalent work experience in a scientific or health related field.
3-5+ years Clinical Research Management of clinical trials.
Rare disease experience highly preferred.
Experience with CTMS and data systems.
Excellent analytical, verbal, and written presentation skills with a working knowledge of Microsoft Office applications including Word, Excel, Access, PowerPoint, and Visio.
Able to work at a fast pace and dynamic work environment; small company experience preferred

#J-18808-Ljbffr