Manager, Clinical Operations

Galvanize is a biomedical platform company operating at the convergence of engineering, biology, and healthcare delivery, aiming to deliver life-changing solutions to patients and their doctors. We design and develop Pulsed Electric Field Systems to achieve meaningful and lasting therapeutic outcomes for patients.

About the role

The Manager of Clinical Operations is responsible for clinical operational planning and execution and oversees the conduct of clinical studies ensuring they are performed in accordance with GCP, company SOPs, and other applicable rules and regulations. The Manager will be responsible for the recruitment, hiring, training, and development of assigned CRA operational staff.

Responsibilities

• Oversee clinical study planning and implementation from site selection through study closure
• Ensure proper oversight of clinical site compliance with Clinical Investigation Plans (CIP), SOPs, FDA regulations, and ICH/GCP guidelines
• Provide oversight to assigned clinical affairs operational staff including training, coaching, and performance management
• Play a central role in identifying, selecting, initiating, and monitoring the performance of clinical sites and studies across the portfolio
• Oversee the development of study-specific training tools and aids to ensure study-level compliance, the trending of metrics, and CIP training
• Oversee all aspects of clinical study monitoring providing direction and accountability for the clinical operations team
• Ensure timely development of study-related plans and documents which may include, but are not limited to CIPs, informed consent forms, recruitment plans, monitoring plans, and data management plans
• May organize committee(s) to review adverse events and protocol deviations
• Ensure adequate document collection and maintenance for audit-ready Trial Master Files
• May serve as the primary point of contact regarding operational questions and escalations
• Work with Sr. Management to communicate critical issues and drive to resolution
• Establish and maintain strong relationships and communication with sites and site staff
• May represent Clinical Operations at internal and/or external audits
• May conduct routine monitoring visits or co-monitoring, start-up and closeout visits, as necessary
• Provide oversight for and assessment of external clinical trial vendors including CROs and core labs
• Develop and maintain relationships with external vendors, CROs, core labs, etc., and keep abreast of industry best practices and trends
• Develop and maintain relationships with cross-functional partners across the enterprise, participating in development activities as requested
• Periodically evaluate clinical SOPs for compliance and continued process improvement
• Identify processes that may need improvement and communicate this to line management
• May develop and manage study-level budgets and operational costs

Requirements

• Bachelor’s degree or equivalent combination of education/experience in life sciences or related field
• Minimum 6 years’ clinical research experience in the medical device industry that includes relevant experience as a previous Clinical Study Manager, Clinical Program Manager, or Clinical Research Manager
• Strong working knowledge of FDA regulations, ICH Guidelines, GCP, ISO 14155, and current industry practices related to the conduct of clinical trials
• Strong interpersonal communication (written and verbal), organizational, and prioritization skills
• Able to work effectively under a fast-paced and changing environment
• Proficient in Microsoft Office products with technical abilities to become proficient quickly with numerous other electronic systems (i.e., eTMF, EDC, and CTMS)
• Detail-oriented, with good organizational and time management skills
• Complete projects with high quality and minimal guidance

Travel

Up to 25%; mainly domestic and some international.

Pay

This role pays between $150,000 and $175,000 per year, and your actual base pay will depend on your location, skills, qualifications, and experience.

Benefits

• Medical, dental, and vision coverage
• Life insurance
• Short- and long-term disability protection
• 401(k)
• Flexible paid time off