Manager, Clinical Operations

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Galvanize

WebsiteLinkedInAll Job Openings

201 - 500 employees

📚 Education

🤝 B2B

🏢 Enterprise

💰 $17.3M Debt Financing - Galvanize on 2019-01

Education • B2B • Enterprise

Galvanize is a corporate training and technical education provider that helps organizations upskill, reskill, and assess engineering and data teams. It delivers customized, competency-based programs—onboarding, modular courses, immersive cohorts, and embedded coaching—focused on AI & Machine Learning, Software Engineering, Data Engineering & Analytics, Cloud & Modern Infrastructure, and Agile/Extreme Programming. Galvanize emphasizes measurable impact and ROI, serving thousands of organizations including Fortune 100 companies and the U. S. Department of Defense.

📋 Description

• Oversee clinical study planning and implementation from site selection through study closure • Ensures proper oversight of clinical site compliance with Clinical Investigation Plans (CIP), SOPs, FDA regulations and ICH/GCP guidelines • Provides oversight to assigned clinical affairs operational staff including training, coaching and performance management • Plays a central role in identifying, selecting, initiating and monitoring the performance of clinical sites and studies across the portfolio • Oversees the development of study-specific training tools and aids to ensure study-level compliance, the trending of metrics and CIP training • Oversees all aspects of clinical study monitoring providing direction and accountability for the clinical operations team • Ensures 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 • Ensures adequate document collection and maintenance for audit-ready Trial Master Files • May serve as the primary point of contact regarding operational questions and escalations • Works with Sr. Management to communicate critical issues and drive to resolution • Establishes and maintains 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 lab, etc. and keep abreast of industry best practices and trends • Develops and maintains relationships with cross-functional partners across the enterprise, participating in development activities as requested • Periodically evaluates clinical SOPs for compliance and continued process improvement • Identifies processes that may need improvement and communicates 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

🏖️ Benefits

• medical, dental, and vision coverage • life insurance • short- and long-term disability protection • 401(k) • flexible paid time off