Manager, Infusion Support Operations

Role Summary

Reporting to the Vice President, AID Program Leader and Head of Translational Medicine, the Manager, Infusion Support Operations will be responsible for providing technical and clinical support both internally and externally during clinical trials and other infusion related activities. This role will work on cross-functional study teams for the execution of clinical trial activities, data interpretation, and communication across all company activities as needed. This individual will interface directly with other functions including Clinical Operations, Technical Operations, Quality, Regulatory Affairs. The Manager, Infusion Support Operations will not work in a clinical care role providing direct patient care. The Manager, Infusion Support Operations will be available to provide training, support, and education to various members of the clinical trial site team including but not limited to the stem cell laboratory personnel, the cell therapy transplant team, and clinical research team on CRISPR drug product handling, storage, administration, and monitoring.

Responsibilities

• Participate in the design and implementation of successful infusion protocols, cross functional SOPs, and scientific training material to support clinical trials. Develop infusion and protocol training materials to support internal and external activities
• Collaborate with internal stakeholders (clinical operations, data management, statistics, safety, regulatory affairs, etc.) to ensure successful translation of the clinical protocol into operational deliverables, and participate in the design and development of shared process improvement programs
• Collaborate with analytical laboratory personnel to assist with drug product thaw and infusion process testing
• Train clinical sites on receipt, storage, thaw, and infusion procedures related to CRISPR Therapeutics drug products and collaborate with clinical infusion sites to ensure subject safety, adherence to GCP, GxP, GDP and compliance with study protocol
• Assess and document the effectiveness of education provided to clinical sites, including the activation of new sites to the clinical trial
• Participate in study site selection by evaluating a site’s ability to comply with CRISPR Therapeutics requirements for receipt, storage, thaw, and infusion procedures
• Provide continuous on-site or remote support for all drug product programs which includes working outside of normal business hours, (i.e. nights, weekends and holidays)
• Work with cross-functional team to identify opportunities to improve processes and products, including apheresis, as needed by GMP manufacturing; this may include updates to vendor procedures or processes and supporting change documentation by CRISPR

Qualifications

• Required: RN and 5-7+ years' clinical experience, preferably in hospital inpatient or pharmacy setting
• Required: Pharm D or PhD 1-3+ years' clinical experience, preferably in hospital inpatient or pharmacy setting
• Required: Excellent oral and written communication skills
• Required: Experience working with MS PowerPoint, MS Word, MS Excel, Teams and SharePoint as well as Zoom video conferencing
• Required: Ability to work collaboratively in a fast-paced, team-based matrix environment
• Required: A thorough understanding of ICH, GCP, GDP and relevant regulatory requirements
• Required: Strong analytical and strategic thinking skills, experience with interacting with medical monitors, development operations (preclinical, clinical operations, regulatory affairs, Quality Assurance) and clinical investigators
• Preferred: Experience with infusion procedures
• Preferred: Experience with clinical education

Skills

• Collaborative – Openness, One Team
• Undaunted – Fearless, Can-do attitude
• Results Orientation – Delivering progress toward our mission, Sense of urgency in solving problems
• Entrepreneurial Spirit – Proactive, Ownership mindset