Sr. Clinical Operations Manager

Sr. Clinical Operations Manager

Rion is a clinical-stage biotechnology company based in Rochester, Minnesota. Rion was founded as a Mayo Clinic Employee Entrepreneurial Program startup company. Rion’s mission is to develop clinically impactful and accessible therapies using innovative regenerative medicine technologies based on extracellular vesicle science. Our proprietary exosome platform has the ability to address significant unmet patient needs in many fields of medicine; accordingly, we are actively pursuing clinical programs in wound healing, cardiovascular diseases, and musculoskeletal disorders. Our ultimate mission is to deliver cutting edge solutions accessible to any patient in need, anywhere in the world.

We are searching for an experienced and driven Sr. Clinical Operations Manager with a background in biotech/pharmaceuticals/CRO. This position is a full-time salary role. Reporting to the Vice President, Global Clinical Development & Operations, this role manages multiple clinical studies from Protocol Concept and Development to Clinical Study Reporting and Disclosure. This is an exciting opportunity for an individual with an MD background, proven track record of clinical protocol development, managing studies, internal cross-functional collaboration and coordination, CRO and vendor management to join a dynamic team working to deliver high quality studies on time and within budget. The role is key to ensuring that study milestones and deliverables are achieved according to agreed quality standards and timelines and that quality of data are acceptable and suitable for regulatory submission. This individual ensures that assigned studies are executed according to ICH/GCP guidelines, applicable regulatory requirements and standard operating procedures.

Essential Duties & Responsibilities:

• Managing study progress from start-up to close-out activities and end of study reporting.
• Assuring adherence to intended timelines to achieve study goals while ensuring compliance with international GCP guidelines/regulations and SOPs/SWPs, identifying risks and implementing risk mitigation plans.
• Coordinating interdisciplinary activities throughout the study.
• Oversight and management of CRO and clinical vendors as appropriate to ensure successful conduct of the clinical trial and to ensure data integrity and quality.
• Oversight and management of multiple clinical trials from early development through licensure.
• Lead completion of study deliverables through active participation in all aspects of study design, execution, analysis and reporting, vendor selection and management, and oversight of investigator selection and management.
• Proactively managing study deliverables and milestones, including identifying and resolving trial related issues (quality, timelines, budget, resources).
• Medical Writing - clinical related deliverables (e.g., Investigator Brochure, clinical protocol development, informed consent & amendments, Annual Reports/DSUR, eCTD clinical modules, response to FDA questions, etc.)
• Ensure audit readiness at all times by assessing and mitigating study compliance with all regulatory requirements (knowledge of GCP, ICH guidelines, trial master file and regulatory requirements for clinical trial management is required)
• Participate in process improvement initiatives including, but not limited to, contributing to generation of Standard Operating Procedures (SOPs), and collaboration with Clinical Quality, Regulatory and Laboratory staff on study compliance initiatives.
• Provide input in the development of clinical trial related documents including but not limited to: protocols, case report forms, informed consents, timelines, project oversight plan, monitoring plans, laboratory manuals, pharmacy manuals, training materials, and site initiation visit slide presentation.
• Effective communication with KOLs and Investigator site staff to support study delivery.
• Contributing to individual and team development through training initiatives and team building activities.